FDA 510(k) Clearances Feed: new medical device clearances and PMA approvals

Get a clean, analysis-ready feed of new FDA medical device 510(k) clearances, plus optional PMA approvals and supplements, straight from the official openFDA API. Filter by FDA product code, advisory committee / medical specialty, applicant company, decision code, clearance type or device name keyword. Each record has computed FDA review days and a direct link to the FDA 510(k) or PMA database page. Turn on "new since last run" mode and schedule it for a daily or weekly alert feed of new FDA device clearances.

No API key, no login, no scraping. The data is official US government public data (openFDA, CC0).

Who it's for

• Medtech competitive intelligence: see the moment a competitor gets a device cleared in your product code. Track predicate trends, new entrants and review times.
• Investors and analysts: follow regulatory milestones for public and private medtech companies. Track 510(k) and PMA activity by company or specialty, and spot De Novo grants.
• Regulatory affairs consultants: benchmark FDA review times (reviewDays) by product code, panel and pathway (Traditional, Special, Abbreviated), and find recent predicates.
• Medtech sales and business development teams: newly cleared devices often mean launches, hiring, and a need for distributors, contract manufacturers, CROs, marketing and launch agencies. Use the feed as a list of companies with a fresh reason to talk.
• Journalists and newsletter writers: get a weekly digest of new AI, robotic, cardiovascular and digital-health device clearances.

What you get (one record per FDA decision)

Field	Example
recordType	510(k), PMA original, PMA supplement
kNumber / pmaNumber + supplementNumber	K262000 / P200026 + S019
deviceName	Sway System (Sports Plus)
applicant, applicantCountry	Sway Medical, Inc., US
productCode, productCodeName, deviceClass, regulationNumber	POM, Computerized Cognitive Assessment Aid For Concussion, 2, 882.1471
advisoryCommittee, advisoryCommitteeCode	Neurology, NE
decisionDate, decisionCode, decisionDescription	2026-10-18, SESE, Substantially Equivalent
dateReceived, reviewDays (computed)	2026-06-15, 125
clearanceType	Traditional, Special, Abbreviated, PMA
thirdPartyReview, expeditedReview, statementOrSummary	false, null, Summary
fdaUrl	Link to the record on the FDA 510(k)/PMA database
PMA only: genericName, supplementType, supplementReason, approvalOrderStatement

Entity-level data only: contact person names and street addresses in the FDA source are dropped on purpose.

Quick start

1. Click Start with the default input {}. You get the 30 newest 510(k) clearances from the last 60 days in a few seconds.
2. Narrow it down with filters, for example:

{
  "advisoryCommittees": ["Cardiovascular", "RA"],
  "deviceNameKeywords": ["catheter", "AI"],
  "includePMA": true,
  "maxItems": 200
}

{ "applicants": ["Medtronic", "Stryker", "Boston Scientific"], "includePMA": true, "includePmaSupplements": false }

{ "productCodes": ["QAS", "LLZ"], "decisionCodes": ["SESE"] }

3. Alert feed (recommended for schedules): set "mode": "sinceLastRun" and a stateKey such as "cardio-watch". Each run then returns only clearances it has not delivered before for that key. Create a Schedule in Apify Console (daily or weekly, e.g. Monday 7 am) and connect a webhook, Slack, email, Google Sheets, Zapier or Make integration to receive the new rows automatically.

{ "mode": "sinceLastRun", "stateKey": "cardio-watch", "advisoryCommittees": ["CV"], "lookbackDays": 60, "maxItems": 500 }

Schedule tip: openFDA refreshes device data about weekly, and FDA decisions appear in it with a lag (the newest records are typically 1-3 weeks old). A daily or weekly schedule in sinceLastRun mode with lookbackDays of 60 catches late-published decisions without duplicates. Check dataLastUpdated in the run summary (OUTPUT record).

Input

Input	Default	Notes
mode	window	window = newest matches in the lookback window. sinceLastRun = only records not delivered before (per stateKey).
lookbackDays	60	Window by FDA decision date (7-3650).
productCodes	all	3-letter FDA product codes.
advisoryCommittees	all	Codes (CV, OR, RA, NE, GU, DE, HO, SU, CH, IM...) or names (Cardiovascular).
applicants	all	Company name words. Any match counts.
decisionCodes	all	SESE, SESK, SESD, DENG (De Novo), PMA APPR, OK30...
deviceNameKeywords	all	Words in the device/trade name.
clearanceTypes	all	Traditional, Special, Abbreviated, Direct.
includePMA	false	Add PMA decisions (class III).
includePmaSupplements	true	Untick to get original PMA approvals only.
maxItems	30	Hard cap on records (and spend).
stateKey	default	One per schedule.
openfdaApiKey	none	Optional free openFDA key for very high volumes.

Different filters are combined with AND. Values within one filter are combined with OR.

Sample output

{
  "recordType": "510(k)",
  "kNumber": "K262000",
  "deviceName": "Sway System (Sports Plus)",
  "applicant": "Sway Medical, Inc.",
  "applicantCountry": "US",
  "productCode": "POM",
  "productCodeName": "Computerized Cognitive Assessment Aid For Concussion",
  "deviceClass": "2",
  "advisoryCommittee": "Neurology",
  "decisionDate": "2026-10-18",
  "decisionCode": "SESE",
  "decisionDescription": "Substantially Equivalent",
  "dateReceived": "2026-06-15",
  "reviewDays": 125,
  "clearanceType": "Traditional",
  "fdaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262000"
}

See sample-output.json for full records.

Pricing

Pay per event (Apify takes care of billing; you only pay for what is delivered):

Event	Price	Charged
apify-actor-start	$0.005	once per run
clearance-record	$0.004	per 510(k) clearance or PMA approval delivered

A default test run (30 records) costs about $0.125. A weekly product-code watch (~10 new clearances/week) costs about $0.045/week. maxItems and Apify's max cost per run cap your spend; the Actor stops delivering when your budget is reached, so you are never charged for more than you set. No separate platform-usage charges: compute is included in the event prices.

FAQ

Why are the newest records a week or more old? openFDA updates device data about weekly, and the FDA publishes decisions after a delay. The Actor reads the official source, so freshness matches openFDA. sinceLastRun mode handles late-published decisions automatically.

Is this data allowed to be reused? Yes. openFDA data is public domain (CC0). This Actor is not affiliated with or endorsed by the FDA. Don't use it for clinical decisions.

Can I get De Novo grants? Yes. De Novo decisions appear in the 510(k) data with decision code DENG.

Rate limits? The Actor makes paced, keyless requests (well under openFDA's limits) and retries politely on throttling.