Over-the-Counter Fingertip Pulse Oximeter Pathway

An example report, for a made-up over-the-counter pulse oximeter. The PDF is what arrives by email. Get one for your device.

Proposed product code: OLK Pulse Oximeter For Over-The-Counter Use High
Regulation: 21 CFR 870.2700 · Class 2
Proposed pathway: 510(k) HighThe route FDA has on record for OLKFDA's goal: a decision in 90 FDA days · fee $28,653, or $7,163 for a small business

What a 510(k) means

You show FDA the device is substantially equivalent to one already on the market: the same intended use, and technology that raises no new questions of safety and effectiveness.

FDA's review goal: A decision within 90 FDA days; days waiting on you do not count
FDA fee from Oct 1, 2026: $28,653, or $7,163 as a small business
Small business saving: $21,490, with gross receipts of $100 million or less
Every year after launch: Establishment registration, $13,785 (no small-business rate)

Small business rate. Qualify first, then pay: send FDA Form 3602N with your latest tax return (and any affiliates') through the CDRH Portal. FDA aims to decide within 60 days, and the status lasts one fiscal year, to September 30, so apply in the year you submit. How to apply

Sources: FDA user fees for FY2027 (Federal Register, July 30, 2026), MDUFA V performance goals, FDA small business program.

High the FDA record says it outright · Medium the record plus one inference · Low a reading of the description; check it

We assumed: The stated spot-check use is intermittent rather than continuous monitoring. The device measures oxygen saturation optically through a fingertip, as is inherent in the described pulse oximeter type.

What the description left out

4 facts could change this report. Answer any of them, in any order, and send: we email you an updated report.

High could change the product code or the pathwayMedium could change the devices to compare with, the standards or the testsLow fills in a detail

MediumWhat oxygen-saturation accuracy will you claim, and over what range?
Within 2% from 70 to 100% · Within 3% from 70 to 100% · Not decided yet
MediumWhat ages will the label say it is for?
Adults 18 and over · Adults and teenagers 12 and over · Anyone over 30 kg
MediumWill the label claim anything beyond spot checks and calling a doctor?
Spot checks only · Spot checks and tracking trends over time · Spot checks during exercise or at altitude
LowWhat does the screen show besides the two numbers?
Only SpO2 and pulse rate · The numbers and a signal-strength bar · The numbers and a low-battery sign

Or add details in your own words

On your own report, you can add what was left out here and get an updated report.

What to confirm next

The first 3 of 13 checks a regulatory consultant would make, in the order of the report.

1 · Classification

Confirm the final labeling preserves OTC spot-check use and does not add diagnosis, screening, treatment-decision or continuous-monitoring claims.
Confirm the precise intended population, measurement performance and use conditions against the OLK clearances and relevant 510(k) summaries.
Confirm whether the final product design includes any alarms, wireless functions or other features not stated in the description.

Show all 13Show fewer

2 · Predicates

Review the complete summaries and indications for use for the four kept predicates before fixing the comparison or final claim language.
Assess whether the MAUDE and recall hazards are relevant to the final design, labeling and home-use risk controls.

3 · Equivalence table

Obtain full predicate comparison tables and reports before relying on numerical performance or testing details omitted from the excerpts.
Determine which predicate testing is applicable to the final device's two-battery design, materials, software and intended home-use conditions.

4 · Standards

Confirm the current recognition status, scope and applicable edition for each selected standard before planning testing.
Confirm battery chemistry and the final patient-contact materials to resolve conditional standards.

5 · Obligations

Confirm applicability of registration, listing, UDI, quality-system and postmarket requirements to the manufacturer's role and final distribution arrangement.
Confirm the proposed label and directions are consistent with OTC spot-check use and the final claims.

6 · Plan and budget

Confirm with a test lab that the clinical accuracy study can be run to the current FDA recommendations on skin pigmentation before fixing the budget.
Confirm the Basic software documentation level against FDA's software guidance once the risk analysis exists.

1. Classification and pathway

OLK (pulse oximeter for over-the-counter use) specifically covers a non-wearable fingertip pulse oximeter used OTC for non-continuous monitoring, matching the stated device and use. High

Every product code considered

Code	Device name	Fits?	What distinguishes it
QWE	Hyperoxia Monitoring Device Adjunct To Pulse Oximetry21 CFR 870.2720 · Class 2 · 510(k)	no	QWE (hyperoxia monitoring device adjunct to pulse oximetry) monitors elevated hemoglobin oxygen saturation as an adjunct, while this device spot-checks oxygen saturation and pulse rate. High
QYU	Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use21 CFR 870.2705 · Class 2 · 510(k)	no	QYU (infant pulse rate and oxygen saturation monitor for OTC use) is intended for infants, while the stated users are adults with COPD. High
OLK	Pulse Oximeter For Over-The-Counter Use21 CFR 870.2700 · Class 2 · 510(k)	yes	The proposed code, for the reason above. High
MUD	Oximeter, Tissue Saturation21 CFR 870.2700 · Class 2 · 510(k)	no	MUD (oximeter, tissue saturation) is exemplified by devices measuring regional tissue saturation, while this device is described as measuring blood oxygen saturation at a fingertip. High
QVT	Monitor For Opioid Induced Impairment Of Oxygenation21 CFR 868.2250 · Class 2 · 510(k)	no	QVT (monitor for opioid induced impairment of oxygenation) detects desaturations resulting from opioid overdose, a purpose not stated for this COPD spot-check device. High
OUW	Infant Positioner, Rx, Use In Highly Monitored Setting21 CFR 880.5680 · Class 1 · 510(k)	no	OUW (infant positioner, Rx, use in highly monitored setting) is an infant positioning device rather than an oximeter. High
MMA	Oximeter, Fetal PulseClass 3 · PMA	no	MMA (oximeter, fetal pulse) concerns fetal oxygen saturation monitoring, while the stated users are adults. High
NMD	Oximeter, Tissue Saturation, Reprocessed21 CFR 870.2700 · Class 2 · 510(k)	no	NMD (oximeter, tissue saturation, reprocessed) is for reprocessed devices, and this product is described as a reusable device rather than a reprocessed device. High
PGJ	Oximeter, Wellness21 CFR 870.2700 · Class 2 · Enforcement discretion	no	PGJ (oximeter, wellness) is for wellness use, while this device is intended for adults with COPD to monitor blood oxygen and contact their doctor when a reading drops. High
DQA	Oximeter21 CFR 870.2700 · Class 2 · 510(k)	maybe	DQA (oximeter) is a broader oximeter code that covers related pulse oximeters, but OLK is preferred because its definition specifically matches OTC fingertip, non-continuous use. High
QEM	Cerebral Oximeter21 CFR 870.2700 · Class 2 · 510(k)	no	QEM (cerebral oximeter) measures cerebral tissue saturation, not fingertip blood oxygen saturation. High
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia21 CFR 868.2500 · Class 2 · 510(k) exempt	no	KLK (monitor, oxygen, cutaneous, for infant not under gas anesthesia) uses a heated skin sensor to monitor cutaneous oxygen tension, not fingertip pulse oximetry. High
CCE	Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling21 CFR 868.1200 · Class 2 · 510(k)	no	CCE (indwelling blood oxygen partial pressure analyzer) measures in-vivo blood oxygen partial pressure with a catheter-tip transducer, not fingertip oxygen saturation. High
NLF	Oximeter, Reprocessed21 CFR 870.2700 · Class 2 · 510(k)	no	NLF (oximeter, reprocessed) is for reprocessed oximeters, whereas the description does not identify this product as reprocessed. High
DQE	Catheter, Oximeter, Fiber-Optic21 CFR 870.1230 · Class 2 · 510(k)	no	DQE (fiberoptic oximeter catheter) estimates blood oxygen saturation using a catheter, unlike this external fingertip device. High
OCH	Oximeter, Infrared, Sporting, Aviation21 CFR 870.2700 · Class 2 · Enforcement discretion	no	OCH (oximeter, infrared, sporting, aviation) is solely for sporting and aviation activities, while this product is intended for home medical monitoring by adults with COPD. High

Pathway

Proposed: 510(k). OLK is Class II and not 510(k) exempt, and its definition expressly covers OTC fingertip pulse oximetry for non-continuous monitoring; the described medical use falls within that intended-use category. High

Why not De Novo: De Novo is not proposed because OLK covers this OTC, fingertip, non-continuous monitoring use.
Why not PMA: PMA is not proposed because the best-fitting candidate OLK is Class II, not Class III.

What would change the answer

If	Then
The labeled use were limited to wellness without a medical purpose.	Reassess whether the product is a medical device and whether PGJ (oximeter, wellness) is the relevant reference. Medium
The device were intended for continuous monitoring or for a different patient population or clinical purpose.	Reassess whether OLK still covers the intended use and whether another product code is more appropriate. Medium

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2. Predicates, ranked with reasons

Ranked by closeness of intended use, then technology and recency; kept predicates have summaries in the FDA records. K211498 and K214115 are OLK OTC fingertip spot-check predicates, while the DQA examples provide related technical and safety comparisons. The summaries for K211498, K214115, K252805 and K252448 are available; no higher-ranked candidate lacks a summary.

Kept

#	Device, as named in the record	Why kept
1	K211498 Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024-11-13 · Cleared · Summary	Nonin Model 3250 OTC Pulse Oximeter (K211498) is an OTC fingertip pulse oximeter for adult spot-checking of SpO2 and pulse rate and is the closest match to the described intended use. High
2	K214115 MightySat -OTCMasimo Corporation · 2024-01-31 · Cleared · Summary	MightySat-OTC (K214115) is a fingertip device for OTC spot-checking of SpO2 and pulse rate in adults, with no-motion use specified. High
3	K252805 YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2026-02-17 · Cleared · Summary	YUWELL® Finger Pulse Oximeter (K252805) is a reusable fingertip spot-check device for home and professional settings, though its stated population includes adults and children and its description does not establish the same OTC indication. High
4	K252448 AViTA Pulse Oximeter (SP61)Avita Corporation · 2026-02-27 · Cleared · Summary	AViTA Pulse Oximeter (K252448) is a spot-check device for SpO2 and pulse rate in home and professional settings, but its summary states prescription use and a broader age group. High

15 devices considered and set aside, and why

Device	Why set aside
K234021 Masimo StorkMasimo Corporation · 2024-05-03 · Cleared · Summary	Masimo Stork (K234021) is a wearable infant and neonatal monitor for spot-checking and continuous monitoring, not an adult fingertip spot-check device. High
K243324 Masimo O3 Regional OximeterMasimo Corporation · 2025-07-17 · Cleared · Summary K254129 Spectrum-2Neko Health AB · 2026-05-22 · Cleared · Summary K214072 Masimo O3 Regional Oximeter SystemMasimo Corporation · 2022-05-06 · Cleared · Summary	The listed MUD examples concern regional or tissue oxygenation, not fingertip measurement of arterial hemoglobin oxygen saturation. High
K201976 SnapshotNIRKent Imaging · 2020-11-10 · Cleared · Summary K211561 INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)Covidien, LLC · 2021-12-05 · Cleared · Summary	These MUD examples concern tissue oximetry systems or sensors rather than the described OTC fingertip device. High
K172962 Nurture RestNeonatal Loving Kare, Inc. · 2018-01-18 · Cleared · Summary	Nurture Rest (K172962) is a positioner for premature infants receiving monitored care, not an oximeter predicate. High
K111007 MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST REMidwest Reprocessing Center, LLC · 2011-06-08 · Cleared · Summary	The NMD clearance concerns reprocessed oximetry sensors, while this description concerns a reusable fingertip device and does not identify reprocessing. High
K252655 Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026-05-11 · Cleared · Summary K250837 Pulse OximeterShanghai Berry Electronic Tech Co., Ltd. · 2025-09-25 · Cleared · Summary K252448 AViTA Pulse Oximeter (SP61)Avita Corporation · 2026-02-27 · Cleared · Summary	These DQA clearances are less suitable than the kept OTC fingertip predicates because their summaries do not establish the same OTC intended use or, for K252448, expressly state prescription use. High
K241758 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability Solutions · 2024-10-22 · Cleared · Summary K222019 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability Solutions · 2022-12-04 · Cleared · Summary	These NLF clearances concern reprocessed pulse oximeter sensors for continuous monitoring in hospitals and hospital-type facilities. High
K172423 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC · 2018-02-20 · Cleared · Summary K160645 PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016-06-16 · Cleared · Summary	These DQE clearances concern oximetry catheters rather than external fingertip pulse oximeters. High

Adverse-event (MAUDE) and recall check

The DQA MAUDE records include reports of incorrect readings, low readings, display problems and device malfunctions, but reports are not incidence estimates and many describe bedside or neonatal use rather than OTC adult spot-checking. DQA recalls also include pulse oximeter reports involving alarms, device power cycling and display problems; those hazards merit review, but their products and use conditions are not necessarily the same as this device. Medium

Reports are what was reported, not how often problems occur. openFDA's disclaimer applies to every number.

Record	What it says
2936999-2026-00302MAUDE report	A report describes an abnormal SpO2 and pulse reading despite stopped breathing; the relationship to the reported death was unknown. High
1282497-2026-00039MAUDE report	A report describes a newborn for whom no valid SpO2 reading was obtained for more than ten minutes despite sensor and monitor changes, which is not the stated adult use. High
96862Recall	The recall concerns bedside SpO2 system alarms not heard or recognized, with potential treatment delay and patient harm; this device is described as having no alarms and for spot-check use. High
94170Recall	The recall reports a potential for a pulse oximeter to power off and on, resulting in loss of monitoring. High
71583Recall	The recall reports potentially missing display segments that could result in data misinterpretation. High

Adverse event reports (MAUDE) and recalls, by product code

Code	Event types	Top device problems	Recalls
DQA	Malfunction 12826, Injury 585, Death 360, Other 166, (blank) 66	Incorrect Measurement 2325, No Audible Alarm 1392, Display or Visual Feedback Problem 1110, Device Operates Differently Than Expected 825, Low Readings 753	16 of 128 on file shown in the trail

Source: FDA's MAUDE and recall databases, as of the openFDA export. Recalls citing any kept 510(k): 21.

2 checks for this section are under What to confirm next

3. Draft substantial-equivalence table

Predicate columns are included only for kept devices with summaries in the FDA records; K211498 is the primary predicate because it is the closest OTC adult fingertip spot-check match. The user-device cells are blank where the description supplies no specification; inferred optical operation is marked as such. Comparisons refer to the primary predicate and identify differences that may need validation rather than asserting substantial equivalence.

Compare with

Attribute	Your device	Primary predicateNonin OTC Pulse Oximeter Model 3250K211498	PredicateMightySat -OTCK214115	PredicateYUWELL® Finger Pulse OximeterK252805	PredicateAViTA Pulse OximeterK252448	Comparison with the primary
General
Product code and regulationHigh	Proposed OLK; 21 CFR 870.2700.	Nonin Model 3250 OTC Pulse Oximeter; the summary describes an OTC finger pulse oximeter.	MightySat-OTC; the summary describes an OTC fingertip pulse oximeter.	DQA; 21 CFR 870.2700, Class II.	DQA; 21 CFR 870.2700, Class II.	Same The proposed OLK classification is consistent with the OTC fingertip use of the primary predicate; DQA is a broader code.
Intended useMedium	Intermittent home spot-checking of blood oxygen and pulse rate by adults with COPD, with a doctor contacted if the reading drops.	Measures and displays functional arterial hemoglobin oxygen saturation and pulse rate for medical use without a prescription; not for diagnosis or screening of lung disease or treatment decisions.	Spot-checking of functional arterial hemoglobin oxygen saturation and pulse rate; treatment decisions should only be under healthcare-provider advice.	Reusable spot-checking device that measures and displays SpO2 and pulse rate; not suitable for continuous monitoring.	Spot-check monitoring of SpO2 and pulse rate in home and professional healthcare settings.	Different The COPD-specific user description and instruction to contact a doctor if readings drop are not stated in the primary predicate's indication; confirm that labeling does not add diagnosis or treatment-decision claims.
Indications for useMedium	Spot-check blood oxygen and pulse rate at home; the user contacts a doctor if the reading drops.	Spot-checking of adults 18 years and older under no-motion conditions; not intended for diagnosis or screening of lung disease or treatment decisions.	Spot-checking of individuals 18 years and older under no-motion conditions; not intended for diagnosis or screening of lung disease.	Spot-checking of adults and children weighing more than 30 kg in professional and home settings; unsuitable for continuous monitoring, motion or low perfusion.	Spot-check monitoring of adults, adolescents and children in home and professional settings under no-motion conditions.	Different The user's description adds COPD as the user population and a doctor-contact action, so the intended labeling and risk communication require review.
Patient populationHigh	Adults with COPD.	Individuals 18 years and older.	Individuals 18 years and older.	Adults and children weighing more than 30 kg.	Adults, adolescents and children.	Different Adults with COPD are a narrower population than the primary predicate's adult population; confirm that performance evidence supports the intended population.
Use environmentMedium	Home.	Spot-checking for medical use; home healthcare requirements are reported in testing.	The stated indication specifies spot-checking but does not specify a use environment in the excerpt.	Professional and home settings.	Home and professional healthcare facility settings.	Same The stated home setting is consistent with the primary predicate's home-healthcare testing and OTC use.
Prescription or over-the-counterHigh	Sold over the counter.	Medical use without a prescription.	Over-the-counter use.	The excerpt identifies professional and home settings but does not specify prescription status.	Prescription only.	Same OTC status matches the primary predicate; the prescription-only K252448 is a less close comparator.
Technology
Principle of operationMedium	Fingertip pulse oximetry; optical measurement is inferred from the described device type.	The summary describes a digit pulse oximeter with an SpO2 sensor and algorithm.	The summary describes a fingertip pulse oximeter using Masimo SET technology.	Red and infrared light and a photodetector measure SpO2; pulse rate is derived from the detected signal.	Red and infrared light pass through pulsatile tissue and are analyzed to determine SpO2 and pulse rate.	Same The described fingertip pulse oximeter use is consistent with the primary predicate, but the founder has not specified the optical architecture or algorithm.
Key componentsHigh	Two AAA batteries; fingertip device; other components not stated.	Battery-operated finger pulse oximeter with a sensor activated by insertion of a digit and a display; includes Bluetooth radio.	Fingertip pulse oximeter with a reusable sensor; the excerpt describes a color display.	LEDs and photodetector on opposite sides of the probe, with a display and two AAA alkaline batteries.	Non-invasive pulse oximeter with a display and battery power; its summary comparison lists an AAA alkaline battery.	Not stated The user description states two AAA batteries but does not specify the sensor, display or other components.
Performance specifications
SpO2 display rangeHigh	not stated	not found	not found	0%–100%.	not found	Not stated The description gives no display range.
SpO2 measurement rangeHigh	not stated	not found	not found	70%–100%.	not found	Not stated The description gives no measurement range.
SpO2 accuracyHigh	not stated	not found	not found	±2% for 70%–100%; no definition below 70%.	not found	Not stated The description gives no accuracy specification.
SpO2 resolutionHigh	not stated	not found	not found	1%.	not found	Not stated The description gives no resolution specification.
PR display rangeHigh	not stated	not found	not found	25–250 bpm.	not found	Not stated The description gives no pulse-rate display range.
PR measurement rangeHigh	not stated	not found	not found	25–250 bpm.	not found	Not stated The description gives no pulse-rate measurement range.
PR accuracyHigh	not stated	not found	not found	±1% or ±1 bpm, whichever is greater.	not found	Not stated The description gives no pulse-rate accuracy specification.
PR resolutionHigh	not stated	not found	not found	1 bpm.	not found	Not stated The description gives no pulse-rate resolution specification.
Safety and standards
Electrical safety and EMCHigh	not stated	The summary reports compliance with IEC 60601-1-2:2014 and home healthcare requirements under IEC 60601-1-11:2015.	not found	The summary reports IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11 testing.	The summary reports electrical safety and EMC testing and states IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11 were relied upon from K223399.	Not stated No safety or EMC testing is stated for the user's device.
Biocompatibility and patient-contact materialsHigh	not stated	The summary reports ISO 10993-1:2018.	not found	The summary reports ISO 10993-1:2018 and cytotoxicity, irritation and sensitization testing; it describes a fingertip cushion made of medical silicone gel.	The excerpt does not report biocompatibility results.	Not stated The device's contact materials and biocompatibility information are not stated.
SoftwareHigh	not stated	The summary reports ANSI AAMI IEC 62304:2006/A1:2016.	not found	The summary reports software verification and validation and Basic Documentation Level.	The excerpt does not report software testing.	Not stated The description does not state whether software is present or provide software documentation.
Features and design
PowerHigh	Two AAA batteries.	Battery operated.	not found	Two AAA alkaline batteries.	Battery powered; the summary comparison lists an AAA alkaline battery.	Different The user's two-cell configuration differs from the one AAA cell stated for K252805 and K252448; this design difference may require power and battery-safety evaluation.
Display and user interfaceHigh	not stated	The device displays numerical SpO2 and pulse rate.	The excerpt describes a color display.	Displays SpO2 and pulse rate on an LED/OLED screen with a visual pulse indicator.	not found	Not stated The description does not state display type or interface details.
ConnectivityHigh	No app; connectivity is not otherwise stated.	Includes a Bluetooth radio.	Connectivity is not stated in the excerpt.	YX110 models can transfer data wirelessly to a mobile device; the summary describes different models.	Connectivity is not stated in the excerpt.	Different The description states no app, unlike the Bluetooth-equipped K211498; the lack of connectivity does not change the described spot-check intended use.
Sterility and reuseMedium	Reusable.	not found	The summary describes a reusable sensor.	Non-invasive, non-sterile and reusable.	not found	Same The described reuse is consistent with K252805's reusable device and K214115's reusable sensor; sterility is not stated for the user's device.

Blanks are blanks. Nothing in this table is guessed.

Testing the predicates reported

What the closest cleared devices tested, from their 510(k) summaries: a starting list for your own test plan.

Test and standard	Reported by	What the summaries report
SpO2 laboratory and clinical hypoxia accuracyISO 80601-2-61:2017	K211498 Nonin OTC Pulse Oximeter Model 3250	The summary reports laboratory and clinical hypoxia accuracy testing and says clinical performance testing was provided; numerical results are not included in the excerpt. High
Clinical SpO2 accuracy and usabilityISO 80601-2-61:2017	K211498 Nonin OTC Pulse Oximeter Model 3250	The summary says clinical accuracy testing and user usability testing were identical to testing for its reference device and describes studies used to substantiate performance across skin pigmentation. High
Home healthcare electrical safety and essential performanceIEC 60601-1-11:2015	K211498 Nonin OTC Pulse Oximeter Model 3250	The summary reports compliance with the home healthcare collateral standard. High
BiocompatibilityISO 10993-1:2018	K211498 Nonin OTC Pulse Oximeter Model 3250 K252805 YUWELL® Finger Pulse Oximeter	K211498 reports ISO 10993-1:2018; K252805 reports ISO 10993-1:2018 and cytotoxicity, irritation and sensitization testing. High
Electrical safety and electromagnetic compatibilityIEC 60601-1-2:2014	K211498 Nonin OTC Pulse Oximeter Model 3250 K252805 YUWELL® Finger Pulse Oximeter K252448 AViTA Pulse Oximeter	The summaries report EMC testing or compliance; K252448 states IEC 60601-1-2 was relied upon from K223399. High
Pulse oximeter performance bench testingISO 80601-2-61:2017	K252805 YUWELL® Finger Pulse Oximeter K252448 AViTA Pulse Oximeter	K252805 reports performance bench testing; K252448 reports laboratory bench testing of SpO2 and pulse-rate measurement accuracy. High
Software verification and validationANSI AAMI IEC 62304:2006/A1:2016	K211498 Nonin OTC Pulse Oximeter Model 3250 K252805 YUWELL® Finger Pulse Oximeter	K211498 reports compliance with the software life-cycle standard; K252805 reports software verification and validation and Basic Documentation Level. High
Usability and human factorsIEC 60601-1-6:2013	K211498 Nonin OTC Pulse Oximeter Model 3250	The summary reports usability testing participation by users and lists the usability collateral standard. High
Wireless testingIEC 60601-1-2:2014	K252805 YUWELL® Finger Pulse Oximeter	The summary includes a wireless testing section; the excerpt does not give the results or specific wireless standard. Medium

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4. Applicable standards

These are candidate recognized standards based on the fingertip pulse oximeter, home use, battery power and predicate testing. Standards for wireless connectivity, medical-image systems, unrelated oximeter technologies and secondary batteries are not included as applicable because the description states no app or connectivity and specifies AAA batteries.

Rec. no.	Standard	Applies	Why
1-139	ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentRecognized: Partial	yes	ISO 80601-2-61 is the pulse oximeter particular standard and is reported in the OTC predicate summaries. High
19-49	IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.Recognized: Complete	Depends	IEC 60601-1 is relevant to basic safety and essential performance of the powered medical device; confirm applicability to the final design. Medium
19-36	ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]Recognized: Partial	Depends	IEC 60601-1-2 addresses EMC and is reported for pulse oximeter predicates; assess for the final device. High
19-38	IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentRecognized: Partial	yes	IEC 60601-1-11 addresses home healthcare equipment, matching the stated home use. High
2-258	ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processRecognized: Partial · transition expires 07/01/2029	Depends	ISO 10993-1 is relevant if the fingertip-contacting materials require biological evaluation; patient-contact materials are not stated. Medium
2-245	ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityRecognized: Complete	Depends	ISO 10993-5 cytotoxicity may apply depending on the risk-based biocompatibility evaluation of contact materials. Medium
2-291	ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritationRecognized: Partial	Depends	ISO 10993-23 irritation may apply depending on the risk-based evaluation of fingertip-contacting materials. Medium
2-296	ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitizationRecognized: Partial	Depends	ISO 10993-10 skin sensitization may apply depending on the risk-based evaluation of fingertip-contacting materials. Medium
13-79	ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]Recognized: Complete	Depends	IEC 62304 is relevant if software is part of the device; the description does not state the software architecture. Medium
5-129	ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1Recognized: Complete	Depends	IEC 62366-1 is relevant to usability engineering for a lay-operated home device. Medium
5-125	ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devicesRecognized: Complete	yes	ISO 14971 provides a risk-management framework relevant to the device's measurements and lay use. Medium
19-54	IEC 60086-5 Edition 5.0 2021-09 Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)]Recognized: Complete	Depends	IEC 60086-5 addresses safety of primary batteries with aqueous electrolyte; confirm its applicability to the specified AAA batteries. Medium
13-122	IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety effectiveness and security - Part 5-1: Security - Activities in the product life cycleRecognized: Complete	no	IEC 81001-5-1 addresses health software and health IT security; no app or connectivity is described. High
13-134	ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeterRecognized: Complete	no	ISO IEEE 11073-10404 concerns communication with personal health devices; no communication function is described. High

Source: FDA recognized consensus standards register, exported 2026-09-13. Recognized is FDA's extent of recognition.

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6. Your plan and budget

What to test, what FDA will expect in the 510(k), what to ask FDA first, and a rough budget and timeline. It builds on the equivalence table, the standards and the obligations without repeating them.

Rough planning total

$70K to $167K or more

FDA fee at the small business rate $7,163 plus testing that applies $63K to $160K or more.

Not in the total

If FDA asks for clinical data: $250K to $2.5M (some simple studies under $100K).yes in the submission list: SpO2 accuracy is shown in a controlled desaturation study in people, including people with darker skin pigmentation. High
Every year after launch: Establishment registration, $13,785 (no small-business rate).

When the money goes out

Small business statusAbout 60 days
FDA aims to decide within 60 days; the status lasts to September 30, so apply again each fiscal year, before you pay the fee.
$0
Pre-SubmissionAbout 70 days
Written answers within 70 days of FDA accepting the request; a meeting, if you ask for one, around day 70 to 75.
$0
about month 2
TestingAsk the labs
No public source states a lab lead time: ask each lab when you ask for its quote.
$63K–$160K+
Clinical dataAsk the labs
No public source states how long a study takes.
$250K–$2.5Mnot in the total
SubmissionThe day you send it
FDA's user fee is due with the submission; the small business rate needs the status above.
$7,163
FDA review90 FDA days
FDA's goal is a decision within 90 FDA days; days waiting on your answers do not count.
$0
about month 5 to 6, plus testing
ClearanceFDA's decision
You may sell once FDA decides and you have registered.
Registration and listingEvery year
Within 30 days of starting, then every year; FDA has no small business rate for it.
$13,785a year, not in the total
Planning total
The amounts above, less the lines not in the total.
$70K–$167K+

About 5 to 6 months from sending the Pre-Sub to FDA's decision, counting only the Pre-Sub and FDA's review goal, one after the other; testing, and any time FDA waits on you, come on top.

Counted: Electrical safety and EMC, biocompatibility. Applies but has no public figure, so not in the range: performance bench testing, software verification and validation, human factors; ask labs to quote.

Not included: consultants and your quality system. For scale, one firm's 2024 price sheet lists $17,500 to prepare a 510(k) or De Novo and $5,000 for a Pre-Sub. The sheet.

A rough planning number from public industry ranges, not a quote.

FDA's fee and review goal are its figures for the route proposed in section 1, shown in full under “What this means” in the summary at the top.

Test plan

Test	Kind	Standard to test to	Rough cost of the kind	Predicates that ran it
SpO2 laboratory and clinical hypoxia accuracy Supports the reading a COPD patient acts on at home: SpO2 accuracy is shown in people taken down through a range of oxygen levels. High	Clinical data	1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02)	$250K to $2.5M	Nonin OTC Pulse Oximeter Model 3250 K211498
Pulse oximeter performance bench testing Verifies SpO2 and pulse-rate accuracy on a simulator and the display's behaviour at the limits of the range. High	Performance bench testing	1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02)	No public figure	YUWELL® Finger Pulse Oximeter K252805 AViTA Pulse Oximeter K252448
Electrical safety and electromagnetic compatibility A battery-powered medical electrical device is tested for basic safety and for interference in the home. High	Electrical safety and EMC	19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]	$50K to $60K	Nonin OTC Pulse Oximeter Model 3250 K211498 YUWELL® Finger Pulse Oximeter K252805 AViTA Pulse Oximeter K252448
Home healthcare electrical safety and essential performance Over-the-counter home use brings in the home healthcare collateral standard. High	Electrical safety and EMC	19-38 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION	$50K to $60K	Nonin OTC Pulse Oximeter Model 3250 K211498
Biocompatibility The finger chamber touches intact skin at every reading, so its materials need cytotoxicity, sensitization and irritation results. High	Biocompatibility	2-258 ISO 10993-1 Fifth edition 2018-08	$13K to $100K or more	Nonin OTC Pulse Oximeter Model 3250 K211498 YUWELL® Finger Pulse Oximeter K252805
Software verification and validation The firmware computes and displays SpO2 and pulse rate. High	Software verification and validation	13-79 ANSI AAMI IEC 62304:2006/A1:2016	No public figure	Nonin OTC Pulse Oximeter Model 3250 K211498 YUWELL® Finger Pulse Oximeter K252805
Usability and human factors Lay users with COPD read the display and decide whether to call a doctor, so the use-related risks need a usability evaluation. High	Human factors	5-129 ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text)	No public figure	Nonin OTC Pulse Oximeter Model 3250 K211498

Where the rough costs come from

Rough public industry ranges for a whole kind of testing, not a quote: a lab usually quotes a kind as one program, so the budget counts each kind once. Read on 2026-09-26.

Performance bench testing: No public figure. No public figure: labs price bench tests one by one, so send them this test list for a quote. Medical Device Academy puts its clients' whole testing budget at around $100K on average. Source: Medical Device Academy, How much does a 510k cost? (Rob Packard, 2021).
Electrical safety and EMC: $50K to $60K. Medical Device Academy puts the total cost of this testing at typically $50K to $60K. Source: Medical Device Academy, How much does a 510k cost? (Rob Packard, 2021).
Biocompatibility: $13K to $100K or more. About $13K for a non-invasive device, up to $100K or more for a long-term implant's implantation studies. Source: Medical Device Academy, How much does a 510k cost? (Rob Packard, 2021).
Software verification and validation: No public figure. No public figure: the work is mostly your team's. FDA's documentation level, Basic or Enhanced, sets how much you write; Medical Device Academy says the documentation typically runs 300 to 1,000 pages. Source: Medical Device Academy, How much does a 510k cost? (Rob Packard, 2021).
Human factors: No public figure. No public figure. FDA recommends at least 15 participants from each distinct user group in the summative (validation) test. Source: FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 3, 2026).
Clinical data: $250K to $2.5M. A human clinical study runs $250K to $2.5 million, and about one 510(k) in ten needs one; some simple studies, such as for infrared thermometers, cost under $100K and resemble bench testing. Source: Medical Device Academy, How much does a 510k cost? (Rob Packard, 2021).

What the submission will contain

Part	Applies	Why
Device description and intended use	yes	Every 510(k) describes the device and its intended use: intermittent home spot checks by adults with COPD. High
Indications for use	yes	The indications must state over-the-counter adult spot-check use at home, as OLK clearances such as K211498 do. High
Substantial-equivalence comparison	yes	The 510(k) compares the device with the kept predicates, as the equivalence table in section 3 lays out. High
Labeling	yes	Over-the-counter labeling must let a lay user act on a low reading safely, including when to contact a doctor. High
Performance bench testing	yes	SpO2 and pulse-rate accuracy on a simulator and display behaviour are verified before the clinical study. High
Electrical safety and EMC	yes	A battery-powered device used at home is tested to 19-49, 19-36 and the home healthcare standard 19-38. High
Biocompatibility	yes	The finger chamber contacts intact skin at every use. High
Sterility and shelf life	no	A reusable device on intact skin is not sold sterile, and no shelf-life claim is stated. Medium
Software documentation	yes	Firmware computes the readings; Basic documentation level fits, since a failure gives a wrong reading that the labeling tells the user to confirm, and K252805 reports Basic. Medium
Cybersecurity	no	The description rules out an app and any connection, so the device is not a cyber device. Medium
Human factors	yes	Lay users acting on a reading at home make use errors a critical task, and K211498 reports usability testing with users. Medium
Clinical data	yes	SpO2 accuracy is shown in a controlled desaturation study in people, including people with darker skin pigmentation. High

Questions for a Pre-Submission

A Pre-Submission is free: FDA charges no fee. FDA answers in writing within 70 days of accepting the request and, if you ask for a meeting, meets you around day 70 to 75. FDA's Q-Submission guidance.

Is K211498, an over-the-counter oximeter, the right primary predicate for a device aimed at adults with COPD, or does naming COPD in the indications raise a new question of safety or effectiveness? Medium
A disease-specific indication at home is the claim closest to the edge of OLK.
How many participants with darker skin pigmentation does FDA expect in the desaturation study, and does it accept testing to the recognized edition of ISO 80601-2-61 (1-139) alone? Medium
The clinical accuracy study is the largest cost and the longest lead time in the plan.
Is a summative usability test with lay users with COPD expected, or does labeling comprehension testing cover the decision to contact a doctor? Low
The answer decides whether a human factors study with at least 15 users is in the budget.
Does FDA agree that the home healthcare standard 19-38 applies with 19-49, and which edition of IEC 60601-1-2 (19-36) it expects? Medium
The predicates reported older editions than the ones recognized now.

Where the money can come from

Public programs to check, not advice: Cove has no part in them, and each program decides who qualifies. Pediatric programs appear when the description mentions children, defense programs when it mentions military use. Read on 2026-09-26.

Program	Typical award
NIH SBIR and STTR Research and development grants from the National Institutes of Health to US small businesses, medical devices among them.	Phase I about $323,090 over 6 months to 2 years; Phase II about $2,153,927 over 1 to 3 years; some topics allow more by waiver.
NSF SBIR and STTR (America's Seed Fund) National Science Foundation grants for startups in most technology areas, medical devices included; you keep full ownership of the company and its IP.	Phase I up to $305,000; Phase II up to $1,250,000 over 24 months.
ARPA-H SBIR and STTR Small business awards from the Advanced Research Projects Agency for Health on set topics, open for a limited time (the 2026 topics close in September and October 2026).	Phase I up to $600,000; Phase II up to $3.5 million.
MedTech Innovator An accelerator for medical device, diagnostic and digital health companies that have raised up to a Series C, with mentors from its corporate partners.	Early-stage (pre-Series B) companies compete for up to $500,000 in funding (2026 cohort).

State matching programs, if you are based there

Program	Typical award
Kentucky SBIR/STTR Matching Funds Matches a federal SBIR or STTR award for a for-profit company based in Kentucky or willing to move there.	Up to $100,000 for Phase I and up to $150,000 for Phase II.
Kansas SBIR/STTR Matching Program Helps a small business headquartered in Kansas prepare a federal SBIR or STTR proposal and matches a Phase I award.	Up to $3,000 for proposal development (a 50% match); up to $25,000 to match a Phase I award.

Other states run similar matching programs; your state's economic development office will know.

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Sources

Every claim about the device in this report comes from these public FDA sources; web search was not a source. The report reads a dated copy of each, so every run can be checked against the same records; the links go to the live versions, where you can look up the same information.

FDA product classification database
FDA 510(k) premarket notification database
FDA recognized consensus standards database · copy of 2026-09-13
eCFR, Title 21, Chapter I, Subchapter H (medical devices) · copy of 2026-09-01
FDA medical device recalls database
FDA MAUDE adverse event database
FDA guidance documents
openFDA downloads · openFDA export 2026-09-07

Planning figures in section 6

The rough costs and timings in section 6 are not FDA records about the device: they are public figures, added the same way to every report, each with the day it was read.

Medical Device Academy, How much does a 510k cost? (Rob Packard, 2021) · read 2026-09-26
Medical Device Academy, standard pricing sheet (April 21, 2024) · read 2026-09-26
FDA guidance: Requests for Feedback and Meetings for Medical Device Submissions, the Q-Submission Program (May 29, 2025) · read 2026-09-26
FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 3, 2026) · read 2026-09-26
FDA user fees for FY2027 (Federal Register, July 30, 2026) · read 2026-09-24
MDUFA V performance goals · read 2026-09-24
FDA small business program · read 2026-09-24

Funding programs in section 6

The programs this report lists, each from its own public page.

NIH SBIR and STTR · read 2026-09-26
NSF SBIR and STTR (America's Seed Fund) · read 2026-09-26
ARPA-H SBIR and STTR · read 2026-09-26
MedTech Innovator · read 2026-09-26
Kentucky SBIR/STTR Matching Funds · read 2026-09-26
Kansas SBIR/STTR Matching Program · read 2026-09-26

Every step, in order

Each record looked up and each decision. Codes, 510(k) numbers and regulations link to FDA's own pages.

1
FDA product classification, word search for ['pulse oximeter', 'oximeter', 'oxygen saturation monitor', 'blood oxygen monitor']
499 product codes scored
2
candidate cap
499 codes matched; kept the 16 matching the most search terms, then by device-name match and 510(k) count. Dropped: QYF (Neonatal Icu Continuous Non-Invasive Blo, 0 510(k)s), DPZ (Oximeter, Ear, 11 510(k)s), LPP (Monitor, Oxygen, Cutaneous, For Uses Oth, 2 510(k)s), GLY (Oximeter To Measure Hemoglobin, 5 510(k)s), DRY (Monitor, Blood-Gas, On-Line, Cardiopulmo, 47 510(k)s), DXY (Implantable Pacemaker Pulse-Generator, 461 510(k)s), OLV (Standard Polysomnograph With Electroence, 65 510(k)s), QYC (Container System For The Processing And , 0 510(k)s), NMB (Catheter, Oximeter, Fiber Optic, Reproce, 0 510(k)s), CAW (Generator, Oxygen, Portable, 288 510(k)s), DTZ (Oxygenator, Cardiopulmonary Bypass, 254 510(k)s), HEP (Monitor, Blood-Flow, Ultrasonic, 4 510(k)s), DTE (Pulse-Generator, Pacemaker, External, 65 510(k)s), CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 122 510(k)s), NJJ (Tonometer, Analyzer, Ocular Blood Flow, 1 510(k)s), NFB (Conserver, Oxygen, 71 510(k)s), LME (Monitor, Blood-Flow, Cerebral, Thermal D, 1 510(k)s), BYG (Mask, Oxygen, 55 510(k)s), BYJ (Unit, Liquid-Oxygen, Portable, 55 510(k)s), JOQ (Generator, Pulse, Pacemaker, External Pr, 18 510(k)s), CAT (Cannula, Nasal, Oxygen, 42 510(k)s), QLG (Integrated Continuous Glucose Monitoring, 9 510(k)s), BZL (Computer, Oxygen-Uptake, 33 510(k)s), QME (Software For Optical Camera-Based Measur, 13 510(k)s), OYX (Bcr/Abl1 Monitoring Test, 6 510(k)s), KPJ (Chamber, Oxygen, Topical, Extremity, 23 510(k)s), BYF (Mask, Oxygen, Low Concentration, Venturi, 19 510(k)s), QDK (Integrated Continuous Glucose Monitoring, 4 510(k)s), KGB (Mask, Oxygen, Non-Rebreathing, 13 510(k)s), BYL (Tent, Oxygen, 11 510(k)s), FOG (Hood, Oxygen, Infant, 9 510(k)s), PJT (Continuous Glucose Monitor Secondary Dis, 2 510(k)s), BZB (Catheter, Nasal, Oxygen, 8 510(k)s), OED (Antimicrobial Blood Pressure Cuff, 2 510(k)s), QNJ (Mass Spectrometry, Microorganism Identif, 2 510(k)s), OSR (Pacemaker/Icd/Crt Non-Implanted Componen, 0 510(k)s), NPP (Reprocessed Blood Pressure Cuff, 1 510(k)s), QWF (Tubing, Long Term Support Greater Than 6, 1 510(k)s), SDY (Loss Of Pulse Notification Software, 1 510(k)s), BYK (Tent, Oxygen, Electrically Powered, 3 510(k)s), BYS (Oxygenator, Long Term Support Greater Th, 3 510(k)s), QAV (High Flow/High Velocity Humidified Oxyge, 3 510(k)s), QTB (Nitric Oxide Generator And Delivery Syst, 0 510(k)s), PYV (Hospital Continuous Glucose Monitoring S, 0 510(k)s), QCD (Continuous Glucose Monitor, Implanted, A, 0 510(k)s), MHX (Monitor, Physiological, Patient(With Arr, 429 510(k)s), QTM (Assayed External Control Material For Mi, 0 510(k)s), DRT (Monitor, Cardiac (Incl. Cardiotachometer, 339 510(k)s), MWI (Monitor, Physiological, Patient (Without, 308 510(k)s), DXN (System, Measurement, Blood-Pressure, Non, 1222 510(k)s), JHC (Acid, Uric, Uricase (Oxygen Rate), 1 510(k)s), OLF (Medevac Use Oxygen Generator, 1 510(k)s), PCM (Portable Liquid Oxygen Unit Stand, 1 510(k)s), LOT (Pulse-Generator, Program Module, 0 510(k)s), LWO (Pulse-Generator, Single Chamber, Sensor , 0 510(k)s), LWP (Implantable Pulse Generator, Pacemaker (, 0 510(k)s), LWW (Pulse-Generator, Single Chamber, Single, 0 510(k)s), NKE (Pulse Generator, Pacemaker, Implantable,, 0 510(k)s), NVZ (Pulse Generator, Permanent, Implantable, 0 510(k)s), OVJ (Pulse Generator, External Pacemaker, Dua, 0 510(k)s), PCW (Implantable Pulse Generator, Programmer , 0 510(k)s), QFV (Implantable Pulse Generator, 0 510(k)s), HGM (System, Monitoring, Perinatal, 215 510(k)s), BZQ (Monitor, Breathing Frequency, 176 510(k)s), NBW (System, Test, Blood Glucose, Over The Co, 510 510(k)s), ONF (Powered Light Based Non-Laser Surgical I, 74 510(k)s), MSX (System, Network And Communication, Physi, 119 510(k)s), GWM (Device, Monitoring, Intracranial Pressur, 105 510(k)s), MWG (System, Oxygen, Aqueous, 0 510(k)s), OGL (Oxygen Administration Kit, 0 510(k)s), QSF (Software Option For Anesthesia Gas Machi, 0 510(k)s), SIL (Wound Dressings Containing Oxygen, 0 510(k)s), CAP (Monitor, Airway Pressure (Includes Gauge, 78 510(k)s), JKA (Tubes, Vials, Systems, Serum Separators,, 236 510(k)s), NOZ (Assay, 1,5-Anhydroglucitol (15ag), 2 510(k)s), BZK (Spirometer, Monitoring (W/Wo Alarm), 61 510(k)s), KNG (Monitor, Ultrasonic, Fetal, 60 510(k)s), DXQ (Blood Pressure Cuff, 199 510(k)s), CHL (Electrode Measurement, Blood-Gases (Pco2, 188 510(k)s), KOC (Accessories, Blood Circuit, Hemodialysis, 182 510(k)s), DTN (Reservoir, Blood, Cardiopulmonary Bypass, 169 510(k)s), DRS (Transducer, Blood-Pressure, Extravascula, 148 510(k)s), DPW (Flowmeter, Blood, Cardiovascular, 138 510(k)s), FLN (Monitor, Electric For Gravity Flow Infus, 39 510(k)s), QOH (Extracorporeal System For Carbon Dioxide, 1 510(k)s), JAF (Monitor, Ultrasonic, Nonfetal, 38 510(k)s), FMK (Single Use Only Blood Lancet With An Int, 110 510(k)s), KLA (Monitor, Esophageal Motility, Anorectal , 31 510(k)s), KMI (Monitor, Bed Patient, 31 510(k)s), KHE (Reagent, Occult Blood, 97 510(k)s), DTM (Filter, Blood, Cardiopulmonary Bypass, A, 96 510(k)s), IWE (Monitor, Patient Position, Light-Beam, 28 510(k)s), KXO (Monitor, Pressure, Intrauterine, 26 510(k)s), LIL (Monitor, Penile Tumescence, 26 510(k)s), KFM (Pump, Blood, Cardiopulmonary Bypass, Non, 84 510(k)s), HFM (Monitor, Uterine Contraction, External (, 23 510(k)s), DSK (Computer, Blood-Pressure, 77 510(k)s), FJK (Set, Tubing, Blood, With And Without Ant, 77 510(k)s), MDB (System, Blood Culturing, 68 510(k)s), JJS (Controls For Blood-Gases, (Assayed And U, 67 510(k)s), DWL (Stocking, Medical Support (To Prevent Po, 64 510(k)s), KZM (Device, Muscle Monitoring, 19 510(k)s), MQS (System, Hemodialysis, Access Recirculati, 18 510(k)s), QBJ (Integrated Continuous Glucose Monitoring, 18 510(k)s), CBT (Arterial Blood Sampling Kit, 58 510(k)s), DTW (Monitor And/Or Control, Level Sensing, C, 17 510(k)s), LKD (Monitor, Carbon-Dioxide, Cutaneous, 17 510(k)s), FLS (Monitor, Apnea, Facility Use, 16 510(k)s), PKU (Insulin Pump Secondary Display, 0 510(k)s), PQF (Sensor, Glucose, Invasive, Non-Adjunctiv, 0 510(k)s), PZE (Sensor, Glucose, Invasive, Non-Adjunctiv, 0 510(k)s), QHJ (Sensor, Glucose, Implanted, Non-Adjuncti, 0 510(k)s), LXC (Monitor, Pressure, Intracompartmental, 15 510(k)s), DPT (Probe, Blood-Flow, Extravascular, 48 510(k)s), MLD (Monitor, St Segment With Alarm, 14 510(k)s), NIG (System, Test, Carbohydrate Antigen (Ca19, 12 510(k)s), KHG (Whole Blood Hemoglobin Determination, 39 510(k)s), GIF (Diluent, Blood Cell, 38 510(k)s), CAK (Microfilter, Blood Transfusion, 36 510(k)s), JTA (Monitor, Microbial Growth, 11 510(k)s), OBH (Monitor, Extracellular Fluid, Lymphedema, 10 510(k)s), OSP (Uterine Electromyographic Monitor, 10 510(k)s), PLC (Sleep Appliances With Patient Monitoring, 10 510(k)s), POS (Physiological Signal Based Seizure Monit, 10 510(k)s), BRZ (Set, Blood Transfusion, 30 510(k)s), MAA (Monitor, Fetal Doppler Ultrasound, 9 510(k)s), MMW (System, Test, Tumor Marker, Monitoring, , 9 510(k)s), LKN (Separator, Automated, Blood Cell And Pla, 27 510(k)s), QRL (Multiple Use Blood Lancet For Single Pat, 27 510(k)s), JBP (Activated Whole Blood Clotting Time, 24 510(k)s), HEL (Monitor, Heart Rate, Fetal, Ultrasonic, 7 510(k)s), GIO (Tube, Collection, Capillary Blood, 22 510(k)s), DWB (Pump, Blood, Cardiopulmonary Bypass, Rol, 21 510(k)s), NZE (Hyperthermia Monitor, 6 510(k)s), MSQ (Test, Urea (Breath Or Blood), 17 510(k)s), QRK (Single Use Only Blood Lancet Without An , 17 510(k)s), HEK (Monitor, Heart Sound, Fetal, Ultrasonic, 5 510(k)s), LQK (Home Uterine Activity Monitor, 5 510(k)s), LZW (Monitor, Spine Curvature, 5 510(k)s), PMS (Peripheral Intravenous (Piv) Infiltratio, 5 510(k)s), QRX (Continuous Glucose Monitor Informed Insu, 5 510(k)s), KSR (Container, Empty, For Collection & Proce, 16 510(k)s), MOT (Irradiator, Blood To Prevent Graft Versu, 16 510(k)s), CCC (Analyzer, Gas, Carbon-Dioxide, Partial P, 15 510(k)s), BSB (Warmer, Blood, Non-Electromagnetic Radia, 14 510(k)s), GKH (Apparatus, Automated Blood Cell Diluting, 14 510(k)s), PZI (Prescription Use Blood Glucose Meter For, 14 510(k)s), DRI (Monitor, Line Isolation, 4 510(k)s), HLL (Monitor, Eye Movement, 4 510(k)s), NFQ (Device, Dental Sonography, For Monitorin, 4 510(k)s), NPB (System, Monitoring, For Progress Of Labo, 4 510(k)s), SAF (Integrated Continuous Glucose Monitor Fo, 4 510(k)s), JOD (Filter, Blood, Cardiotomy Suction Line, , 12 510(k)s), KSF (Kit, Quality Control For Blood Banking R, 12 510(k)s), JIO (Blood, Occult, Colorimetric, In Urine, 11 510(k)s), CAR (Monitor, Spinal-Fluid Pressure, Electric, 3 510(k)s), FLA (Monitor, Temperature, Dialysis, 3 510(k)s), HEI (Monitor, Heart-Valve Movement, Fetal, Ul, 3 510(k)s), NCW (System, Test, Her-2/Neu, Monitoring, 3 510(k)s), OCR (Lung Sound Monitor, 3 510(k)s), OQU (Airway Monitoring System, 3 510(k)s), SBH (Integrated Continuous Glucose Monitor Fo, 3 510(k)s), CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-, 10 510(k)s), GKT (Separator, Automated, Blood Cell, Diagno, 10 510(k)s), KRK (Manometer, Blood-Pressure, Venous, 9 510(k)s), LCH (Tonometer (Calibration And Q.C. Of Blood, 9 510(k)s), DTY (Sensor, Blood-Gas, In-Line, Cardiopulmon, 8 510(k)s), KSQ (Device, Blood Mixing And Blood Weighing, 8 510(k)s), KSX (Substance, Blood Grouping Of Non-Human O, 8 510(k)s), PJE (Blood/Plasma Collection Device For Dna T, 8 510(k)s), QFR (Coagulation System For The Measurement O, 8 510(k)s), QNR (Blood Pump For Ecmo, Long-Term (> 6 Hour, 8 510(k)s), SAN (Automated Antimicrobial Susceptibility T, 8 510(k)s), KXN (Monitor, Cardiac, Fetal, 2 510(k)s), MLC (Monitor, St Segment, 2 510(k)s), NFS (Device, Jaw Tracking, For Monitoring Jaw, 2 510(k)s), NPF (Monitor, Apnea, Home Use, 2 510(k)s), PHU (Intra-Abdominal Pressure Monitoring Devi, 2 510(k)s), QFJ (Intravascular Bleed Monitor, 2 510(k)s), QJB (Adjunct Monitor, Protein Calorie Malnutr, 2 510(k)s), SBA (Integrated Continuous Glucose Monitoring, 2 510(k)s), SEM (Sub-Scalp Implanted Electroencephalogram, 2 510(k)s), FIR (Pump, Blood, Extra-Luminal, 7 510(k)s), GJE (Tray, Blood Collection, 7 510(k)s), QJT (Rigid Sterilization Container With Softw, 1 510(k)s), QOK (Hardware And Software For Optical Camera, 1 510(k)s), DSJ (Alarm, Blood-Pressure, 6 510(k)s), KSB (Set, Transfer (Blood/Plasma), 6 510(k)s), KSS (Supplies, Blood-Bank, 6 510(k)s), OOX (Automated Occult Blood Analyzer, 6 510(k)s), PBZ (Image Processing Device For Estimation O, 6 510(k)s), FKJ (Filter, Blood, Dialysis, 5 510(k)s), GLE (Mixer, Blood Tube, 5 510(k)s), SGR (Noninvasive Positive Airway Pressure Sys, 2 510(k)s), CBA (Monitor, Air Embolism, Ultrasonic, 1 510(k)s), HMC (Monitor, Eye Movement, Diagnostic, 1 510(k)s), NBK (System, Test, (Ihc), Tumor Marker, Monit, 1 510(k)s), NTY (System, Test, Fibrin/Fibrinogen Degradat, 1 510(k)s), OBI (Catheter, Pressure Monitoring, Cardiac, 1 510(k)s), PHV (Continuous Glucose Monitor Retrospective, 1 510(k)s), QBE (Cranial Sound Monitor, 1 510(k)s), QBQ (System, Microbial Growth Monitor Of Norm, 1 510(k)s), QDL (Integrated Continuous Glucose Monitoring, 1 510(k)s), QII (Integrated Continuous Glucose Monitoring, 1 510(k)s), SAX (Home Monitoring Ophthalmic Optical Coher, 1 510(k)s), SBO (Bed-Patient Activity Monitoring System, 1 510(k)s), SFU (Glucose Range Monitoring System, 1 510(k)s), FIG (Clamp, Tubing, Blood, Automatic, 4 510(k)s), FJD (Detector, Leak, Blood, 4 510(k)s), HGW (Sampler, Blood, Fetal, 4 510(k)s), KSE (Refrigerator, Freezer, Blood Storage, 4 510(k)s), KSZ (System, Test, Automated Blood Grouping A, 4 510(k)s), KZL (Device, Warming. Blood And Plasma, 4 510(k)s), ODX (Autonomous Extracorporeal Blood Leak Det, 4 510(k)s), SET (Immunoassay Blood Test For Amyloid Patho, 4 510(k)s), JWO (Device, Blood Volume Measuring, 3 510(k)s), QZX (Positive Blood Culture Processor For Ino, 3 510(k)s), QFB (Isocapnic Ventilation Device, 1 510(k)s), SGY (Hypothermic Machine Perfusion System And, 1 510(k)s), QAB (Pacing System Analyzer, 0 510(k)s), FKB (Connector, Blood Tubing, Infusion T, 2 510(k)s), FML (Chair, Blood Donor, 2 510(k)s), LLB (System, Blood, Extracorporeal And Access, 2 510(k)s), NTW (System, Blood Collection, Rna Stabilizat, 2 510(k)s), OUS (Methicillin Resistant Staphylococcus Aur, 2 510(k)s), PRH (Positive Blood Culture Identification An, 2 510(k)s), PRJ (Capillary Blood Collection Device For Al, 2 510(k)s), QBX (Direct Blood Bacterial Nucleic Acid Dete, 2 510(k)s), QMA (Blood Collection Device For Cell-Free Nu, 2 510(k)s), EXZ (Equipment, Photographic, For Physiologic, 0 510(k)s), GXS (Monitor, Alpha, 0 510(k)s), GXT (Monitor, Lesion Temperature, 0 510(k)s), HEJ (Monitor, Hemic Sound, Ultrasonic, 0 510(k)s), HEQ (Monitor, Pressure, Arterial, Fetal, Ultr, 0 510(k)s), HFP (Monitor, Phonocardiographic, Fetal, 0 510(k)s), HGO (Monitor, Electroencephalographic, Fetal , 0 510(k)s), JEZ (Monitor, Lung Water Measurement, 0 510(k)s), JXQ (Monitor, U.V., Glc, 0 510(k)s), LII (Monitor, Intracranial Pressure, Implante, 0 510(k)s), LMY (Monitor, Skin Resistance/Skin Temperatur, 0 510(k)s), MOH (Monitor, Heart Rate, Fetal, Non-Stress T, 0 510(k)s), MTL (Monitor,Test,Hiv-1, 0 510(k)s), MUT (Kit, Test For Nuclear Matrix (Numa) Prot, 0 510(k)s), NHF (Monitor, Orthotic/Prosthetic, 0 510(k)s), NSD (Test, Fluorescence In Situ Hybridization, 0 510(k)s), NVA (Cancer Monitoring Test System, Soluble M, 0 510(k)s), OAW (Cancer Monitoring Test System, Soluble M, 0 510(k)s), PFY (Low Patient Acuity Monitoring System, 0 510(k)s), PSP (Intracranial Pressure & Temperature Moni, 0 510(k)s), PWW (Fever Monitoring Kit, 0 510(k)s), PXE (Pressure Monitoring (Air/Gas) Kit, 0 510(k)s), QLJ (Patient Monitor With Independent Remote , 0 510(k)s), QNY (Remote Or Wearable Patient Monitoring De, 0 510(k)s), QUM (Human Immunodeficiency Virus (Hiv) Viral, 0 510(k)s), RBD (Video Monitor, Medical Imaging, Color, 0 510(k)s), RBE (Video Monitor, General Purpose, Color, 0 510(k)s), RBF (Video Monitor, Medical Imaging, Monochro, 0 510(k)s), RBG (Video Monitor, General Purpose, Monochro, 0 510(k)s), RHF (Digital Display Monitor, 0 510(k)s), RIK (Television Or Monitor, Non-Crt, Non-Medi, 0 510(k)s), DGQ (Whole Blood Plasma, Antigen, Antiserum, , 1 510(k)s), FJC (Detector, Blood Level, 1 510(k)s), FKL (Insert, Pump, Blood, 1 510(k)s), HGK (Endoscope, Fetal Blood Sampling (And Acc, 1 510(k)s), JKP (Chromium-51, Blood Volume, 1 510(k)s), KSO (Centrifuge, Blood-Bank For In Vitro Diag, 1 510(k)s), KSW (System, Processing For Frozen Blood, 1 510(k)s), KSY (Boxes, View, Blood Grouping, 1 510(k)s), NRS (Control Material, Blood Circulating Epit, 1 510(k)s), OSL (Control, Fecal Occult Blood, 1 510(k)s), QUD (Blood Detection Capsule, 1 510(k)s), FET (Endoscopic Video Imaging System/Componen, 100 510(k)s), QOT (Emergency Ventilator, 0 510(k)s), QOV (Critical Care Ventilator, 0 510(k)s), QOW (Ventilatory Assistance Helmet, 0 510(k)s), BSA (Warmer, Blood, Electromagnetic Radiation, 0 510(k)s), BSD (Analyzer, Gas, Nitrogen, Partial Pressur, 0 510(k)s), JED (Analyzer, Oxyhemoglobin Concentration, B, 0 510(k)s), JIP (Blood, Occult, Enzymatic Method, In Urin, 0 510(k)s), KST (System, Blood Collection, Vacuum-Assiste, 0 510(k)s), LHE (Controller, Closed-Loop Blood Glucose, 0 510(k)s), LSX (Controller, Closed-Loop, Blood-Pressure, 0 510(k)s), MDP (Separator For Therapeutic Purposes, Memb, 0 510(k)s), MMH (Blood Establishment Computer Software An, 0 510(k)s), MSK (Immunoassay For Blood Tacrolimus, 0 510(k)s), MTQ (Software, Blood Virus Applications, 0 510(k)s), MWO (Reagent, Blood Bank, Quality Control, 0 510(k)s), MYK (Kit, Cord Blood Collection, 0 510(k)s), MYW (Irradiation, Blood Indicators, 0 510(k)s), MYX (System, Blood Collection, Vacuum-Assiste, 0 510(k)s), MYY (Separator, Semi-Automated, Blood Compone, 0 510(k)s), MYZ (Kit, Test (Donors), For Bloodborne Patho, 0 510(k)s), MZA (Test, Equipment, Automated Bloodborne Pa, 0 510(k)s), MZG (Test, Residual, Wbc In Leukoreduced Bloo, 0 510(k)s), NGK (Test, Occult Blood, Over The Counter, 0 510(k)s), OAO (Cord Blood Processing System And Storage, 0 510(k)s), OFE (Central Venous Blood Pressure Kit, 0 510(k)s), OFI (Laser Blood Flow Kit, 0 510(k)s), OFM (Phlebotomy Blood Collection Kit, 0 510(k)s), OFZ (Blood Specimen Collection Kit (Excludes , 0 510(k)s), OIA (Neonatal Blood Collection Kit And Screen, 0 510(k)s), OIB (Blood And Urine Collection Kit (Excludes, 0 510(k)s), OIC (Blood Alcohol Kit (Excludes Hiv Testing), 0 510(k)s), OOF (Cryogenic Cord Blood Storage Container, 0 510(k)s), OQX (Self-Contained Blood Grouping , 0 510(k)s), ORL (Whole Blood Pre-Treatment T-Cell Enrichm, 0 510(k)s), OZD (Temporary Non-Roller Type Left Heart Sup, 0 510(k)s), PBC (Manual Blood Grouping And Antibody Test , 0 510(k)s), PJF (Illuminator System For Blood Products, 0 510(k)s), PMQ (Peripheral Blood Processing Device For W, 0 510(k)s), POQ (Blood Transfusion Kit, 0 510(k)s), PQD (Blood Specimen Collection Convenience Ki, 0 510(k)s), PRO (Anti-Regurgitation Blood Tubing Kit, 0 510(k)s), PTN (Reservoir, Blood, Cardiopulmonary Bypass, 0 510(k)s), PVS (Fetal Blood Sampling Kit (Excludes Hiv T, 0 510(k)s), PWO (Blood Administration Kit, 0 510(k)s), PWP (Blood Borne Pathogen Response Kit, 0 510(k)s), PYX (Temporary Non-Roller Type Right Heart Su, 0 510(k)s), PZT (Peripheral Blood Processing Device For O, 0 510(k)s), PZV (Peripheral Blood Processing Device For C, 0 510(k)s), QBZ (Automated Platform Consisting Of Softwar, 0 510(k)s), QHM (Serology Tests Used For Infectious Disea, 0 510(k)s), QHO (Nucleic-Acid Tests Used For Infectious D, 0 510(k)s), QHR (Blood Grouping Reagent, 0 510(k)s), QHT (Reagent Red Blood Cells, 0 510(k)s), QOC (Temporary Non-Roller Type Left Or Right , 0 510(k)s), QPW (Reagents And Transportation Supplies, So, 0 510(k)s), QRM (Multiple Use Blood Lancet For Multiple P, 0 510(k)s), QZG (Menstrual Blood Collection Device, 0 510(k)s), SDM (Nucleic Acid Test Used For Screening Of , 0 510(k)s), SDN (Serology Test Used For Screening Of Cada, 0 510(k)s), PDQ (Neurosurgical Nerve Locator, 36 510(k)s), NRY (Catheter, Thrombus Retriever, 114 510(k)s), PMN (Assayed External Control Material For Mi, 32 510(k)s), QYX (Outpatient Cardiac Telemetry, 21 510(k)s), QTZ (Radiological Image Processing Software F, 9 510(k)s), POV (Semen Analysis Device, 28 510(k)s), PSY (Whole Slide Imaging System, 23 510(k)s), PYT (Device, Fertility Diagnostic, Contracept, 7 510(k)s), OEO (Automated Digital Image Manual Interpret, 6 510(k)s), POL (Neurovascular Mechanical Thrombectomy De, 18 510(k)s), OIU (Test, Epithelial Ovarian Tumor Associate, 5 510(k)s), OWP (Biological Sterilization Process Indicat, 5 510(k)s), QCC (Insulin Pump Therapy Adjustment Calculat, 5 510(k)s), QKM (A Chemical Vapor Sterilization Multivari, 5 510(k)s), OVY (Liquid Chemical Processing System, 4 510(k)s), QPP (Implantable Post-Surgical Kinematic Meas, 4 510(k)s), NQI (System, Immunomagnetic, Circulating Canc, 13 510(k)s), PEN (Gram-Negative Bacteria And Associated Re, 11 510(k)s), OVK (Cytokeratin Fragments 21-1 Eia Kit, 3 510(k)s), PCS (Liver Iron Concentration Imaging Compani, 3 510(k)s), PKQ (Computerized Cognitive Assessment Aid, 3 510(k)s), QNV (Adjunctive Hemodynamic Indicator With De, 3 510(k)s), QRS (Device For Sleep Apnea Testing Based On , 3 510(k)s), QVB (Biological Sterilization Indicator With , 3 510(k)s), QZW (Over-The-Counter Device To Assess Risk O, 3 510(k)s), OMR (Vessel Guard Or Cover, 10 510(k)s), PZO (Software For Visualization Of Vascular A, 10 510(k)s), NUW (Stimulator, Muscle, Powered, Dental, 9 510(k)s), QDC (Dna-Based Test For Minimal Residual Dise, 2 510(k)s), QMI (Nucleic Acid Amplification Test For The , 2 510(k)s), QYW (Hospital Cardiac Telemetry, 2 510(k)s), SAK (Software Device To Aid In The Prediction, 2 510(k)s), SFE (Endoscopic Video Imaging System / Softwa, 2 510(k)s), PAM (Gram-Positive Bacteria And Their Resista, 7 510(k)s), QHA (X-Ray Angiographic Imaging Based Coronar, 7 510(k)s), NHT (Assay, Nucleic Acid Amplification, Bacil, 6 510(k)s), NQL (System, Test, Amino Acids, Free Carnitin, 5 510(k)s), NRP (Sirolimus Test System, 5 510(k)s), OKC (Implanted Subcutaneous Securement Cathet, 5 510(k)s), QVP (Sars-Cov-2 Serology Test, 5 510(k)s), OCS (Endoscopic Video Imaging System/Componen, 1 510(k)s), OLD (Internal Polymerase Chain Reaction Con, 1 510(k)s), OQQ (Diagnostic Ultrasonic Transducer, Roboti, 1 510(k)s), OUG (Medical Device Data System, 1 510(k)s), OVA (Complete Gene Expression Profiling Acces, 1 510(k)s), PLZ (Ocular Pattern Recorder, 1 510(k)s), POX (Enzyme Immunoassay, Oxcarbazepine Metabo, 1 510(k)s), PUJ (Voriconazole Test System, 1 510(k)s), QDR (Plazomicin Test System, Immunoassay, 1 510(k)s), QQB (Prognostic Test For Assessment Of Liver , 1 510(k)s), QTE (Thymidine Kinase Activity, 1 510(k)s), QVC (Ventilator Waveform Analysis Software, 1 510(k)s), QWP (Optical Neurosurgical Nerve Locator, 1 510(k)s), QWZ (Prognostic Test For Assessment Of Chroni, 1 510(k)s), QXS (Chromogranin A, 1 510(k)s), SAR (Adjunctive Hemodynamic Indicator With De, 1 510(k)s), SBC (Dental Image Analyzer, 1 510(k)s), SBE (Digital Physical/Chemical Sterilization , 1 510(k)s), SHB (Creatinine Test System For At Home Presc, 1 510(k)s), SHL (Ear, Nose, And Throat Image Analyzer, 1 510(k)s), NOY (Agents, Embolic, For Treatment Of Benign, 4 510(k)s), NXX (Fish (Fluorescent In Situ Hybridization), 4 510(k)s), OAH (Fish (Fluorescent In Situ Hybridization), 4 510(k)s), PRE (Rt-Qpcr Assay For Mrna Transcript Immune, 4 510(k)s), NRF (Material, Quality Control, Semen Analysi, 3 510(k)s), NRN (Leeches, Medicinal, 3 510(k)s), NZS (Fish (Fluorescent In Situ Hybridization), 3 510(k)s), OPL (Multiplex Immunoassay For Measles Virus,, 3 510(k)s), PII (Candida Species Nucleic Acid Detection S, 3 510(k)s), PQW (Alpha-D-Galactosidase A (Gla) Newborn Sc, 3 510(k)s), QUT (Deformability Cytometry For Sepsis Risk , 3 510(k)s), SEL (Securement Wound Dressing For Reduction , 3 510(k)s), NID (Assay, Proliferation, In Vitro, T Lympho, 2 510(k)s), NVQ (Bacteriophage And Controls, B. Anthracis, 2 510(k)s), OJQ (Cardiac Allograft Gene Expression Profil, 2 510(k)s), OMI (Multiplex Flow Immunoassay, T. Gondii, R, 2 510(k)s), OUF (Everolimus Immunoassay, 2 510(k)s), OVQ (Chronic Lymphocytic Leukemia Fish Probe , 2 510(k)s), PEO (Fungal Organisms, Nucleic Acid-Based Ass, 2 510(k)s), PFA (Non-Invasive Central Venous Manometer, 2 510(k)s), PJC (Newborn Screening Specimen Collection Pa, 2 510(k)s), PJI (Severe Combined Immunodeficiency Disorde, 2 510(k)s), MDS (Sensor, Glucose, Invasive, 0 510(k)s), MVK (Wearable Automated External Defibrillato, 0 510(k)s), NRZ (Ablation System, High Intensity Focused , 0 510(k)s), OZA (Test, Urea Adult And Pediatric (Breath),, 0 510(k)s), PBA (Ecarin Clotting Time, 0 510(k)s), PDR (Computer-Assisted Personalized Sedation , 0 510(k)s), POH (Mr-Guided Focused Ultrasound System, 0 510(k)s), QIC (Hiv-1 Genotyping Assay Using Ngs Technol, 0 510(k)s), QLM (Intensive Care Unit, Respiratory Failure, 0 510(k)s), QVW (Generator, Measurement, And/Or Delivery , 0 510(k)s), RFJ (Process Control, 0 510(k)s), RIF (Smart Meter, 0 510(k)s), SCU (Dna And Rna Oncology Controls, 0 510(k)s), OAX (Plasmodium Spp. Detection Reagents, 1 510(k)s), OBN (Humidifier, Respiratory, Mask (Direct Pa, 1 510(k)s), OPM (Multiplex Immunoassay For T. Gondii, Rub, 1 510(k)s), PFG (Dna Fish Probe Kit For Specimen Characte, 1 510(k)s), PFT (Reagents For Molecular Diagnostic Test S, 1 510(k)s), PKB (Autosomal Recessive Carrier Screening Ge, 1 510(k)s), PYN (Fish (Fluorescence In Situ Hybridization, 1 510(k)s), QJE (Muscular Dystrophy Newborn Screening Tes, 1 510(k)s), QNX (External Compression Device For Internal, 1 510(k)s), QSA (Circulating Tumor Cell (Ctc) Enrichment , 1 510(k)s), QUE (Spinal Muscular Atrophy Newborn Screenin, 1 510(k)s), QXY (Oscillometric-Based, Over-The-Counter, A, 1 510(k)s), QYO (Hematopoietic Cell Enrichment Kit , 1 510(k)s), SAC (Adamts13 Activity Test System, 1 510(k)s), SBP (Simple Point-Of-Care Nucleic Acid-Based , 1 510(k)s), SBY (High Throughput Sequencing Based Tumor P, 1 510(k)s), SCX (Immunoassay For Host Biomarkers Of Sepsi, 1 510(k)s), SES (Non-Factor Replacement Product Test Syst, 1 510(k)s), SGT (Electromagnetic Stimulator For Healthy M, 1 510(k)s), SGW (Device To Detect Antibodies To Hepatitis, 1 510(k)s), SHR (Device For Open Surgical Explant Of Endo, 1 510(k)s), SIF (Software Device System For Estimation Of, 1 510(k)s), NJE (Intracranial Neurovascular Stent, 0 510(k)s), NOO (Clamp, Dialysis Arm, 0 510(k)s), NPE (Material, Embolization, Neurovascular, P, 0 510(k)s), NRX (Complement 4d (C4d) And Complement Recep, 0 510(k)s), NWY (Test, Qualitative, Detection Of Dengue I, 0 510(k)s), NYY (Stimulator, Muscle, Powered, With Limite, 0 510(k)s), OBA (Polymerizing, Neurovascular Embolization, 0 510(k)s), OHQ (Multi-Analyte Controls Unassayed, 0 510(k)s), OKR (Ventricular Bypass (Assist) Device, 0 510(k)s), ORG (Platelet And Plasma Separator For Bone G, 0 510(k)s), OXR (5-Fluorouracil Assay, 0 510(k)s), OYY (Leukemia Translocation Panel Multiplex T, 0 510(k)s), PAQ (Test, Nr2 Antibody, 0 510(k)s), PAV (Catheter, Neuro-Vasculature, Occluding B, 0 510(k)s), PCK (Pediatric Ventricular Assist Device, 0 510(k)s), PEF (Heparin Flush In 0.45% Sodium Chloride, 0 510(k)s), PHP (System, Colorectal Neoplasia, Dna Methyl, 0 510(k)s), PJQ (Agent, Occluding, Vascular, Permanent, 0 510(k)s), PKI (Fully Subcutaneous Implanted Hemodialysi, 0 510(k)s), PNK (Fluorescence In Situ Hybridization, Chro, 0 510(k)s), PQQ (Data Acquisition Software, 0 510(k)s), PQT (Alpha-L-Iduronidase (Idua) Newborn Scree, 0 510(k)s), PQU (Alpha-D-Glucosidase (Gaa) Newborn Screen, 0 510(k)s), PQV (ß-Glucocerebrosidase (Gba) Newborn Scree, 0 510(k)s), PRF (Docetaxel / Paclitaxel Assay, 0 510(k)s), QCL (Acid-Sphingomyelinase (Asm) Newborn Scre, 0 510(k)s), QCM (ß-Galactocerebrosidase (Galc) Newborn Sc, 0 510(k)s), QGU (Hemoglobin For Donor Testing, 0 510(k)s), QHS (Anti-Human Globulin, 0 510(k)s), QLO (Immunoadsorption Column For Emergency Us, 0 510(k)s), QWN (Stent Graft, Infrapopliteal, Venous Arte, 0 510(k)s), QYI (Ablation Catheter, Renal Denervation, 0 510(k)s), SCK (Ldt, Non-Molecular Antisera For Rare Rbc, 0 510(k)s), SDK (Transdermal Test For Assessment Of Glome, 0 510(k)s), SGV (Agent, Absorbable Hemostatic, Collagen W, 0 510(k)s). Pass --codes to force one in.
3
classification rows kept as candidates
QWE, QYU, OLK, MUD, QVT, OUW, MMA, NMD, PGJ, DQA, QEM, KLK, CCE, NLF, DQE, OCH
4
eCFR 21 CFR 870.2720
not in our eCFR copy
5
eCFR 21 CFR 870.9 (limits of exemption)
read
6
eCFR 21 CFR 870.2705
not in our eCFR copy
7
eCFR 21 CFR 870.2700
read
8
eCFR 21 CFR 868.2250
read
9
eCFR 21 CFR 868.9 (limits of exemption)
read
10
eCFR 21 CFR 880.5680
read
11
eCFR 21 CFR 880.9 (limits of exemption)
read
12
eCFR 21 CFR 868.2500
read
13
eCFR 21 CFR 868.1200
read
14
eCFR 21 CFR 870.1230
read
15
FDA 510(k) database for QWE
1 clearances; 1 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
16
FDA 510(k) database for QYU
2 clearances; 2 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
17
FDA 510(k) database for OLK
2 clearances; 2 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
18
FDA 510(k) database for MUD
74 clearances; 15 most recent kept; 30 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
19
FDA 510(k) database for QVT
1 clearances; 1 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
20
FDA 510(k) database for OUW
1 clearances; 1 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
21
FDA 510(k) database for MMA
0 clearances; 0 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
22
FDA 510(k) database for NMD
2 clearances; 2 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
23
FDA 510(k) database for PGJ
0 clearances; 0 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
24
FDA 510(k) database for DQA
726 clearances; 15 most recent kept; 40 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
25
FDA 510(k) database for QEM
1 clearances; 1 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
26
FDA 510(k) database for KLK
47 clearances; 4 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
27
FDA 510(k) database for CCE
23 clearances; 4 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
28
FDA 510(k) database for NLF
27 clearances; 15 most recent kept; 4 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
29
FDA 510(k) database for DQE
19 clearances; 15 most recent kept; 2 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
30
FDA 510(k) database for OCH
0 clearances; 0 most recent kept; 0 older rows matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
31
510(k) summaries fetched from FDA on demand
K211498, K214115
32
510(k) summaries from FDA
10 digested (only those whose name or indications match the grep): K172962, K211498, K214115, K222019, K234021, K241758, K243324, K252448, K252655, K252805
33
MAUDE adverse event reports for DQA
read; 6 narratives matched /pulse oximeter|oximeter|oxygen saturation|SpO2 monitor|pulse rate/
34
FDA recall database for QWE
0 records
35
FDA recall database for QYU
0 records
36
FDA recall database for OLK
0 records
37
FDA recall database for MUD
6 product records in 4 recall events; 4 most recent kept plus 0 older ones matching the grep
38
FDA recall database for QVT
0 records
39
FDA recall database for OUW
2 product records in 1 recall events; 1 most recent kept plus 0 older ones matching the grep
40
FDA recall database for MMA
0 records
41
FDA recall database for NMD
0 records
42
FDA recall database for PGJ
0 records
43
FDA recall database for DQA
128 product records in 46 recall events; 8 most recent kept plus 8 older ones matching the grep
44
FDA recall database for QEM
0 records
45
FDA recall database for KLK
3 product records in 3 recall events; 3 most recent kept plus 0 older ones matching the grep
46
FDA recall database for CCE
0 records
47
FDA recall database for NLF
3 product records in 1 recall events; 1 most recent kept plus 0 older ones matching the grep
48
FDA recall database for DQE
14 product records in 3 recall events; 3 most recent kept plus 0 older ones matching the grep
49
FDA recall database for OCH
0 records
50
FDA recall database search for the listed K numbers
21 recalls cite one of them
51
FDA recognized standards search (search terms in titles, horizontal set, --std terms)
29 entries; ISO 13485 in register: no (0 entries)
52
eCFR obligation sections
807.20, 807.21, 807.22, 807.65, 807.81, 807.85, 807.87, 807.92, 820.1, 820.3, 820.5, 820.7, 820.10, 820.35, 820.40, 820.45, 801.1, 801.5, 801.15, 801.20, 801.30, 801.61, 801.109, 830.20, 830.300, 803.50, 806.10, 812.2, 812.3, 812.20
53
FDA guidance documents searched for the terms
7 documents match
54
FDA guidance catalog, title search
2 entries (any center)
55
FDA PMA database for MMA
3 original PMAs
56
Federal Register final orders
1 final order(s) on disk
57
Decision: classification
proposed OLK (510(k)); 16 codes weighed
58
Decision: predicates
4 kept, 8 discarded, 5 safety records cited
59
Decision: standards and obligations
14 standards listed, 7 obligations
60
Decision: plan
7 tests planned, 10 of 12 submission parts apply, 4 Pre-Sub questions
61
Citation check
every code, K number, recognition number, recall, MAUDE report, CFR section and guidance file found in a record
62
Second opinion
a second model read the bundle and the draft before it was sent

Over-the-Counter Fingertip Pulse Oximeter Pathway

What a 510(k) means

What the description left out

What to confirm next

1 · Classification

2 · Predicates

3 · Equivalence table

4 · Standards

5 · Obligations

6 · Plan and budget

1. Classification and pathway

Every product code considered

Pathway

What would change the answer

2. Predicates, ranked with reasons

Kept

Adverse-event (MAUDE) and recall check

Adverse event reports (MAUDE) and recalls, by product code

3. Draft substantial-equivalence table

Testing the predicates reported

4. Applicable standards

5. What must exist before you can submit or sell

6. Your plan and budget

Not in the total

When the money goes out

Test plan

What the submission will contain

Questions for a Pre-Submission

Where the money can come from

State matching programs, if you are based there

Sources

Planning figures in section 6

Funding programs in section 6

Every step, in order