FDA 510(k) Device Clearances Search
Pricing
$2.00 / 1,000 clearances
FDA 510(k) Device Clearances Search
Pricing
$2.00 / 1,000 clearances
Rating
0.0
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Developer
Rakesh Pai
Maintained by CommunityActor stats
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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
| Field | Name | Description |
|---|---|---|
deviceName | Device name | Words in device name |
applicant | Applicant | Company name |
productCode | Product code | 3-letter FDA product code |
sinceDate | Decided since | YYYY-MM-DD |
maxResults | Max results | Maximum 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.