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FDA 510(k) Device Clearances Search
x402
FDA 510(k) Device Clearances Search is a paid API for AI agents from agent402.tools, paid per call via x402, $0.004/call, status unknown (last checked 2026-10-17).
Search FDA 510(k) premarket clearance records by applicant, product code, K number, or device name, returning decision details, clearance type, device class, and regulation info.
Price / call$0.004
Success—
StatusUnknown
How this service works
Search FDA 510(k) premarket clearances (openFDA) by applicant, three-letter product code, K number or device name: decision and date, clearance type, device class, regulation number, the FDA classification name, medical specialty, and a link to the FDA record. Newest decision first; the answer says how many clearances matched. Live FDA data, no key.
Output
Returns a structured response with the total number of matched clearances, and for each clearance: the K number, applicant name, device name, decision date, clearance type, device class, FDA regulation number, FDA classification name, medical specialty, and a link to the official FDA record. Results are sorted newest decision first. Includes flags for whether results are truncated and a data disclaimer.
Example use cases
Regulatory due diligence on device company
“Pull the last 10 FDA 510(k) clearances for Boston Scientific so I can review their recent regulatory approvals, including the device class and clearance dates.”
Verify specific 510(k) clearance by K number
“Look up FDA 510(k) clearance K233210 and tell me the decision date, clearance type, applicant name, and which medical specialty it falls under.”
Market research on cleared devices in category
“Search FDA 510(k) clearances for insulin pumps and give me the 5 most recent ones — I need the applicant names, decision dates, and device classes.”
Technical details
Endpoint
GEThttps://agent402.tools/api/device-510k?utm_source=zero.xyzWhen to prefer
Use this endpoint when you need to look up FDA 510(k) premarket clearance records directly from live FDA data without requiring an API key. It is ideal for regulatory research, competitive intelligence on medical device companies, verifying specific clearances by K number, or exploring which devices have been cleared under a particular product code or FDA classification. Prefer this over manual FDA website searches when you need structured, machine-readable results.
Side effects
- No matches found if the K number, product code, or applicant name is misspelled or doesn't exist in FDA data
- Partial results if more clearances exist than the requested limit (truncated flag set to true)
- API timeout or unavailability if the upstream openFDA service is down
- Invalid query parameter types (e.g. non-numeric limit) may cause request failure
- Product codes that don't correspond to any 510(k) records return zero results
Input
Schema · Request body
| Field | Type | Description |
|---|---|---|
| inputrequired | object | |
| output | object |
Tags
x402
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