Pathwayby Cove QMS

FDA pathway report

Which FDA pathway is your device on?

Describe your device and we will email you a report built from FDA's public records: the product code FDA uses for devices like yours, the route to market that code puts you on, the cleared devices closest to yours, and a rough budget. It is free, and usually ready a few minutes after you confirm your email.

A few sentences on what it does, who uses it and where. Leave out anything confidential and anything about patients.

We send the report to this address. By sending this form you also agree that we may email you about Cove. Every email has an unsubscribe link.

What the tool read to write that example

product codes matched and scored
499
codes weighed one by one, each with a reason
16
cleared devices compared, 4 kept as predicates
19
510(k) summaries read
10
FDA-recognized standards weighed
14

What you get

What is in the report

A PDF report, and a link to the same report online for 30 days. Every claim in it cites an FDA record. Where the records say nothing, the report leaves the field blank and says so. The excerpts here are from the example report, for a made-up over-the-counter pulse oximeter.

  1. Classification and pathway

    The product code, its regulation and device class, the route to market, and the other codes it considered and ruled out.

    Example report, section 1Open it in the report
    • OLK
      Pulse Oximeter For Over-The-Counter Use21 CFR 870.2700 · Class 2
      yes

      OLK (pulse oximeter for over-the-counter use) expressly covers a fingertip device for OTC, non-continuous monitoring, which matches the described sale and spot-check use. High

    • DQA
      Oximeter21 CFR 870.2700 · Class 2
      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
      no

      QEM (cerebral oximeter) measures cerebral tissue saturation, not fingertip blood oxygen saturation. High

    3 of the 16 product codes weighed, each with the reason it fits or does not.

  2. Predicates

    The cleared devices closest to yours, ranked, with their 510(k) numbers and the reason each was kept.

    Example report, section 2Open it in the report
    1. 1
      K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024-11-13 · Cleared

      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. 2
      K214115MightySat -OTCMasimo Corporation · 2024-01-31 · Cleared

      MightySat-OTC (K214115) is a fingertip device for OTC spot-checking of SpO2 and pulse rate in adults, with no-motion use specified. High

    2 of the 4 predicates kept. 15 more devices were set aside, each with a reason.

  3. Equivalence table

    Your device beside the top predicates, attribute by attribute, filled only from their public summaries.

    Example report, section 3Open it in the report
    AttributeYour devicePrimary predicateComparison
    Power
    High
    Two AAA batteries.
    Battery operated.
    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.

    Prescription or over-the-counter
    High
    Sold over the counter.
    Medical use without a prescription.
    Same

    OTC status matches the primary predicate; the prescription-only K252448 is a less close comparator.

    Display and user interface
    High
    Not stated
    The device displays numerical SpO2 and pulse rate.
    Not stated

    The description does not state display type or interface details.

    3 of 23 rows, against the primary predicate, Nonin OTC Pulse Oximeter Model 3250 (K211498). What you did not state stays blank.

  4. Standards

    The FDA-recognized standards likely to apply, and which of them depend on details you have not given.

    Example report, section 4Open it in the report
    • 1-139
      ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
      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
      Depends

      IEC 60601-1 is relevant to basic safety and essential performance of the powered medical device; confirm applicability to the final design. Medium

    • 13-122
      IEC 81001-5-1 Edition 1.0 2021-12
      no

      IEC 81001-5-1 addresses health software and health IT security; no app or connectivity is described. High

    3 of the 14 standards weighed: one that applies, one that depends on a detail, one that does not.

  5. What must exist before you submit

    The testing, labeling, registration and quality system FDA expects to be in place.

    Example report, section 5Open it in the report
    4 of the 7 obligations listed, each with the regulation it comes from.

  6. Plan and budget

    What to test, what the submission will contain, what to ask FDA first, and a rough budget and timeline from public figures, with where the money can come from.

    Example report, section 6Open it in the report

    Rough planning total

    $70K to $167K or more

    FDA's fee at the small business rate, $7,163, plus the testing that applies.

    1. Small business statusAbout 60 days
      $0
    2. Pre-SubmissionAbout 70 days
      $0
    3. about month 2
    4. TestingAsk the labs
      $63K–$160K+
    5. Clinical dataAsk the labs
      $250K–$2.5Mnot in the total
    6. SubmissionThe day you send it
      $7,163
    7. FDA review90 FDA days
      $0
    8. about month 5 to 6, plus testing
    9. ClearanceFDA's decision
    10. Registration and listingEvery year
      $13,785a year, not in the total
    11. Planning total
      $70K–$167K+
    A rough planning number from public industry ranges, not a quote.

How it is checked

Written by software, so built to be checked

The software checks its own citations, a second model reads the result, and every claim shows you where it came from so that you can check it too.

Every citation has to be in the records

Before a report goes out, every product code, 510(k) number, regulation and standard in it is checked against the FDA records gathered for your device. One that is not there is refused.

OLKK21149821 CFR 870.27001-139

Each one links to FDA's own page.

Every claim says how sure it is

Each answer carries one of three marks, so you can see what comes straight from a record and what is a reading of your description.

High
The FDA record says it outright.
Medium
The record plus one inference.
Low
A reading of the description. Check it.

A second model reads it before you do

A second AI model reviews every report against the same records. When it disagrees, the report says so at the top: what the second reading disputes, and the question that would settle it.

DraftCitations checkedSecond modelSentSent with a second opinion

What it is not

The report is a draft written by software from public records. It is not regulatory advice and it is not an FDA decision. A second AI model checks every report before we send it, and a regulatory professional should read it before you rely on it.

Why it is free

We are building a quality system for medical device startups, and this is how we meet teams early. We may email you about Cove. You can unsubscribe from any email in one click.

What happens to your description

The AI models that read it run with zero data retention: the providers keep no copy after answering and do not train on it. We delete the description and the report 30 days after sending it. We keep your email address and minimal details about the report: product code and proposed pathway. Email us and we delete those too.

Find the pathway for your device

A few sentences about the device and an email address. The report is free.

Describe your device