FDA 510(k) Device Clearances Search — Fast API
Pricing
$0.25 / 1,000 fda 510(k) clearances
FDA 510(k) Device Clearances Search — Fast API
Search public FDA 510(k) device clearance records through openFDA by applicant, device name, product code, committee, K number, or decision date.
Pricing
$0.25 / 1,000 fda 510(k) clearances
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Piven Core
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15 days ago
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Search FDA 510(k) device-clearance records through the public openFDA API and export structured clearance rows.
Use it for medical-device regulatory research, competitor research, product-code analysis, clearance monitoring, device-market research, and automated FDA-data workflows.
Common use cases
- Search 510(k) clearances by applicant or device name
- Research devices by FDA product code or advisory committee
- Look up an exact K number
- Filter clearances by decision-date range
- Build structured clearance datasets for regulatory or market research
What you get
Each billable row represents one 510(k) clearance and can include K number, applicant, device name, product code, committee, clearance type, decision code/description/date, received date, third-party/expedited flags, applicant location, openFDA annotations and exact source provenance.
Source
https://api.fda.gov/device/510k.json
openFDA documents that an API key is not required for normal public use. The 510(k) endpoint currently permits up to 1,000 records in a single request.
Input
Search by applicant, device name, FDA product code, advisory committee, exact K number, or decision-date range. Leave filters blank to browse the source-default clearance list.
The Store default saves at most 25 rows.
Important limitations
V1 deliberately does not join the separate FDA Device Classification endpoint and does not fetch decision summaries or other documents.
A 510(k) clearance record should not be interpreted as a medical recommendation, a guarantee of device safety or effectiveness, or evidence that two devices are clinically equivalent for a particular use. This Actor reports source records; important regulatory conclusions require review of the applicable FDA materials.
Pricing
Only successfully saved clearance rows are billed. Exact openFDA “No matches found” responses become one non-billed summary row; other source failures remain failures.
Private candidate target: $0.25 per 1,000 clearance rows, subject to live economics and a final Store-price recheck.
Public release is a separate decision.
About Piven Core
Built and maintained by Piven Core — focused data APIs and automation utilities for reliable, production-ready workflows.
Learn more: https://pivencore.com
