fda_device_510k_clearances
Finds US FDA 510(k) clearances by applicant (maker) and/or device name, newest decision first: K number, device, decision, clearance type, review time and device class. Answers "is this device FDA cleared?" and "what has this competitor had cleared recently?" for MedTech founders, regulatory consultants and investors. Source: FDA 510(k) premarket notification database via openFDA. Covers 510(k) only; high-risk Class III devices go through PMA (see fda_device_pma_approvals) and De Novo grants are not included. (cost: 1 credit)
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| limit | No | integer, optional, 1-50, number of clearances to return, default 10 | |
| device | No | string, optional (applicant or device required), device name as submitted, e.g. "glucose monitor" | |
| applicant | No | string, optional (applicant or device required), company that submitted the 510(k), e.g. "Dexcom" |