FDA Medical Device Clearances: 510(k) & PMA Approvals (openFDA) avatar

FDA Medical Device Clearances: 510(k) & PMA Approvals (openFDA)

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FDA Medical Device Clearances: 510(k) & PMA Approvals (openFDA)

FDA Medical Device Clearances: 510(k) & PMA Approvals (openFDA)

Try for free

Official FDA medical device 510(k) clearances and PMA approvals from openFDA: device name, company, product code, device class, specialty, decision, dates and review time. Filter by device, company, code or date.

Pricing

from $0.50 / 1,000 device records

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Developer

Pankaj Bhatia

Pankaj Bhatia

Maintained by Community

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Bookmarked

2

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1

Monthly active users

5 days ago

Last modified

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Get official FDA medical device decisions from the openFDA device API. Choose 510(k) premarket notifications (more than 170,000 clearances since 1976) or PMA approvals and supplements for high-risk devices. Each row has the 510(k) or PMA number, device name (or trade and generic name), company, its city, state and country, product code, device class, regulation number, medical specialty, decision date and code, the decision (for example Substantially Equivalent), date received, review time in days, clearance type, third-party and expedited flags, and a link to the FDA database page. You can filter by device name, company, product code, specialty and decision date range. No login or API key is needed.

Who is it for?

  • Medtech competitive intelligence and regulatory teams following competitors' clearances and predicate devices.
  • Sales and business development teams finding companies that just cleared new devices.
  • Investors and analysts measuring FDA review times and approval volumes by specialty.
  • Consultants and researchers building 510(k) and PMA databases.

How to use it

  1. Choose the database (510(k) is the default).
  2. Optionally enter a device name, company, product codes, specialty code (for example CV, RA or NE) or a decision date range.
  3. Set Max results and click Start. The newest decisions come first.

Input example

{"database": "510k", "deviceName": "artificial intelligence", "specialty": "RA", "decisionDateFrom": "2026-01-01", "maxResults": 500}

Output example

{"database": "510(k)", "kNumber": "K262000", "deviceName": "Sway System (Sports Plus)", "applicant": "Sway Medical, Inc.", "applicantState": "OK", "productCode": "POM", "deviceClass": "2", "medicalSpecialty": "Neurology", "decisionDate": "2026-10-18", "decision": "Substantially Equivalent", "reviewDays": 125, "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262000"}

How much does it cost?

Pay-per-event: a small fee per device record returned, plus a tiny per-run start fee. There is no subscription and no separate platform usage cost. For example, 1,000 records cost about $0.50. Searches with no matches and error rows are not charged. Use Max results or Maximum cost per run to cap your spending.

Use it through the API, integrations or AI agents

Run it from the Apify API, on a schedule, or connect it to Make, Zapier, n8n or Google Sheets. AI agents can find and call it through the Apify MCP server. Output is clean JSON with the same fields on every run.

FAQ

Is it legal? Yes. openFDA is the FDA's official public data API, and its data is in the public domain. The tool leaves out contact person names and street addresses and keeps only the company name and location. It is not affiliated with or endorsed by the FDA.

How fresh is it? openFDA updates device data weekly.

Is there a limit? openFDA allows paging through up to about 25,000 records per query. Use date ranges to pull more.

Can I use it for medical decisions? No. Like openFDA itself, this data is for research and business use, not medical advice.

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