fda_device_510k
Search FDA 510(k) premarket clearance decisions to verify medical device equivalence to legally marketed devices using specific criteria like device name, company, or regulation number.
Instructions
Search 510(k) premarket clearance decisions (174K+ since 1976). A 510(k) demonstrates a device is substantially equivalent to a legally marketed device.
Example searches:
'advisory_committee:cv' — cardiovascular devices
'openfda.regulation_number:868.5895' — by regulation number
'device_name:"pacemaker"' — by device name
'applicant:"Medtronic"' — by company
Count fields: country_code, advisory_committee, clearance_type.exact, decision_code
Input Schema
TableJSON Schema
| Name | Required | Description | Default |
|---|---|---|---|
| search | No | OpenFDA search query. Examples: 'field:value', 'field:"Exact Phrase"', 'field:[20200101+TO+20231231]', '_exists_:field'. Combine with '+AND+', '+OR+', '+NOT+'. | |
| limit | No | Max results (default 10, max 100) |