FDA Medical Device Classification
openfda_devices.reference.classificationSearch FDA medical device classification database — 7,000+ product codes with risk class and regulatory requirements. Returns device name, product code, device class (1=low/exempt, 2=moderate/510k, 3=high/PMA), medical specialty, regulation number, definition, life-sustain/implant flags. Filter by device name, product code, device class, or specialty description. Device class determines the regulatory pathway: Class I (General Controls), Class II (510k), Class III (PMA). Source: FDA CDRH device classification 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. |