FDA 510(k) Device Clearances Search avatar

FDA 510(k) Device Clearances Search

Pricing

$2.00 / 1,000 clearances

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FDA 510(k) Device Clearances Search

FDA 510(k) Device Clearances Search

Pricing

$2.00 / 1,000 clearances

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Developer

Rakesh Pai

Rakesh Pai

Maintained by Community

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1

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a day ago

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Search FDA 510(k) premarket clearances by device name, applicant company, product code and decision date. Returns K number, applicant, device, decision, class, panel and summary link.

Data source: openFDA device 510(k) API. Official public data, no API key, no login and no scraping of protected pages. Results are returned as clean, flat JSON that is ready for spreadsheets, databases, BI tools and AI agents.

What can you use it for?

  • Track competitor device clearances
  • Find med-device companies (lead gen)
  • Regulatory pathway research for a product code
  • New-clearance alerts
  • Use it as a tool from AI agents through the Apify MCP server, or schedule it and send new results to Slack, Google Sheets or a webhook

Input

FieldNameDescription
deviceNameDevice nameWords in device name
applicantApplicantCompany name
productCodeProduct code3-letter FDA product code
sinceDateDecided sinceYYYY-MM-DD
maxResultsMax resultsMaximum clearances (newest first)

Example input

{
"deviceName": "glucose monitor",
"maxResults": 5
}

Output

Each result is one dataset item with these fields: kNumber, applicant, deviceName, decisionDate, decision, dateReceived, productCode, deviceClass, regulationNumber, advisoryCommittee, clearanceType, thirdParty, city, state, country, contact, url.

Example output (real result, long fields shortened)

{
"kNumber": "K122370",
"applicant": "Bayer Healthcare",
"deviceName": "CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR",
"decisionDate": "2013-09-26",
"decision": "Substantially Equivalent",
"dateReceived": "2012-08-06",
"productCode": "NBW",
"deviceClass": "2",
"regulationNumber": "862.1345",
"advisoryCommittee": "Clinical Chemistry",
"clearanceType": "Traditional",
"thirdParty": false,
"city": "Mishawaka",
"state": "IN",
"country": "US",
"contact": "ROGER SONNENBURG",
"url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122370"
}

Download the results as JSON, CSV, Excel or XML, or read them through the Apify API.

Pricing

This Actor uses pay-per-event pricing. You pay $0.002 per clearance returned, plus standard Apify platform usage, which is small because the Actor only calls lightweight APIs. You are never charged for results that are not returned. To cap spending, set a maximum cost per run in the run options.

Tips

  • Start with a small max-results value to check your filters, then scale up.
  • Schedule the Actor (for example daily) with a "since" date filter where available to get change alerts.
  • The data comes straight from the official source, so its freshness and completeness depend on that publisher.

Disclaimer

This Actor is not affiliated with or endorsed by the data publisher. Verify critical decisions against the official source.