FDA 510(k) Premarket Clearances
openfda_devices.clearance.premarket_510kSearch FDA 510(k) premarket clearance submissions — 175,000+ cleared medical devices. Returns k_number, device name, applicant, decision (SESE=cleared), decision date, product code, advisory committee specialty, and clearance type (Traditional/Special/Abbreviated). Filter by device name, k-number, applicant, or product code. A 510(k) clearance means FDA determined the device is substantially equivalent to a legally marketed predicate device. Useful for market research, competitive analysis, and regulatory pathway planning. Source: FDA CDRH 510(k) database, US public domain.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| skip | No | Number of records to skip for pagination (default 0). | |
| limit | No | Number of records to return (1–99, default 10). | |
| search | No | OpenFDA search expression using Lucene syntax. Single field: device_name:"pacemaker" or recall_status:"Ongoing". Combined: device_name:"insulin pump"+AND+recall_status:"Ongoing". Omit to return recent records sorted by date. |
Output Schema
| Name | Required | Description | Default |
|---|---|---|---|
| error | No | Present only when the call failed. Includes error code, message, request_id, and any provider-specific extras. | |
| result | No | Tool response payload. Shape varies per tool — consult the tool description and inputSchema. May be an object, array, string, or number depending on the upstream provider response. |