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FDA 510(k) Device Clearances
x402
FDA 510(k) Device Clearances is a paid API for AI agents from x402-filings.datalayer.workers.dev, paid per call via x402, $0.02/call, status unknown (last checked 2026-10-13).
Retrieves FDA 510(k) medical device clearance records including device name, applicant, decision date, product code, device class, regulation number, and advisory committee, with clearances-per-year breakdown.
Price / call$0.02
Success—
StatusUnknown
How this service works
FDA 510(k) clearances for medical devices: which devices were cleared to market, the applicant, the decision date, product code, device class, regulation number and advisory committee, plus a clearance-per-year breakdown. Search by device name, applicant company or K-number. Pairs with the adverse-events and enforcement endpoints for full medtech diligence.
Output
Returns a list of FDA 510(k) clearance records, each containing the device name, applicant company, decision date, K-number, product code, device class, regulation number, and advisory committee. Also includes a clearances-per-year breakdown for trend analysis. Results are filterable by device name keyword, applicant, K-number, and date range.
Example use cases
Medtech due diligence on a device maker
“I'm doing diligence on a startup that makes cardiac monitors — can you pull their FDA 510(k) clearances from Becton Dickinson, limit to 25, and tell me what device classes and product codes they've been cleared for?”
Verify clearance status for a specific device
“Can you look up FDA 510(k) clearance K213456 and tell me the applicant, the decision date, and what advisory committee reviewed it?”
Track device clearance trends over time
“Show me all FDA 510(k) clearances for glucose monitoring devices between 2018-01-01 and 2023-12-31, up to 100 results, so I can see how many were cleared each year.”
Technical details
Endpoint
GEThttps://x402-filings.datalayer.workers.dev/v1/fda/device-clearances?utm_source=zero.xyzWhen to prefer
Use this endpoint when you need structured, searchable FDA 510(k) clearance data for medical devices — especially for medtech due diligence, regulatory verification, or competitive research. Pairs with the FDA adverse-events and enforcement endpoints on the same provider for comprehensive regulatory picture. Prefer over manual FDA database searches when programmatic, filterable access by device name, company, K-number, or date range is needed.
Side effects
- No records found for an obscure or misspelled device name — returns empty result set
- K-number format mismatch (e.g. missing leading K) returns no results
- Date range too narrow returns empty list
- limit parameter out of range (not 1-100) may return validation error
- Applicant name variation (abbreviation vs full legal name) may miss records
Input
Schema · Request body
| Field | Type | Description |
|---|---|---|
| inputrequired | object | |
| output | object |
Tags
x402
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