fda_device_510k
Search over 174,000 FDA 510(k) premarket clearance decisions since 1976 to check if a medical device is substantially equivalent to a legally marketed device.
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
| 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) |