FDA Medical Device Classification
openfda_devices.reference.classificationSearch FDA medical device classifications by name, product code, class, or specialty to identify risk class, regulation number, and required regulatory pathway (Class I, II 510(k), III PMA).
Instructions
Search 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. |