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US Medical Device Clearances — 510(k) & PMA Decisions

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Track US medical device 510(k) clearances and PMA approvals by date, device keyword, product code or applicant: decision, device class, specialty, links. Data: openFDA device API (CC0), not affiliated.

Pricing

from $1.50 / 1,000 result returneds

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0.0

(0)

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plaindata

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Monthly active users

3 days ago

Last modified

Input examples

{ "pathway": "both", "lastDays": 30, "maxItems": 100 }
{ "pathway": "510k", "searchText": "catheter", "lastDays": 90 }
{ "applicant": "Medtronic", "decidedFrom": "2026-01-01", "maxItems": 500 }
{ "productCodes": ["DQY", "LWP"], "lastDays": 365 }

Output (one row per decision)

Field	Meaning
pathway	510(k) or PMA
decisionNumber, supplementNumber	K-number or PMA number (+ supplement)
deviceName, tradeName	Device name; trade name for PMA
applicant, city, state, country	Submitting company and location (no street address)
productCode, deviceClass, regulationNumber, medicalSpecialty	Classification
dateReceived, decisionDate, decisionCode, decision	Timeline and outcome (510(k) decision text or PMA approval-order statement)
submissionType, reason	510(k) clearance type / PMA supplement type and reason
statementOrSummary, thirdPartyReview, expeditedReview	Review details
fdaUrl	Link to the official database entry
source	Data source statement

Data source & licence

openFDA device 510(k) and PMA endpoints. openFDA data is dedicated to the public domain under CC0: "You can copy, modify, distribute and perform the work, even for commercial purposes, all without asking permission." GMDN content is not used.

Privacy

The 510(k) contact-person field and street addresses are never output. Any e-mail address or phone number inside text is masked.

Notes

Do not rely on this data for medical decisions; openFDA results are unvalidated. Requests are spaced (about two per second). Not affiliated with or endorsed by the U.S. Food and Drug Administration.

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