Search 174,000+ FDA 510(k) Clearances
Find predicate devices, track competitor clearances, and build your 510(k) submission strategy with the most comprehensive search tool.
Last updated: February 2026
What You Can Do with the 510(k) Database
Predicate Search
Find potential predicate devices for your 510(k) submission by searching product codes, device names, or company names across 174K+ clearances.
Competitive Intelligence
Track competitor device clearances. Know when new devices enter your market space and how they compare to your predicate chain.
PMS Evidence
Monitor new clearances for similar devices as part of your post-market surveillance. Export evidence for regulatory inspections.
Complete FDA 510(k) Data
What is included
- 174,000+ clearance records from FDA
- K-number, applicant, decision date
- Product code and device classification
- Clearance type (traditional, special, abbreviated)
- Advisory committee and review panel
- Full-text search across all fields
Beyond search: device monitoring
TrueMedDevice goes beyond simple search. Set up a device profile to continuously monitor new 510(k) clearances relevant to your device — along with recalls, PMA approvals, and enforcement actions from both FDA and Health Canada.
Each new signal is scored for relevance (HIGH, MID, LOW) with reasons and suggested actions. Your RA/QA team reviews, approves, or overrides each signal to build inspection-ready evidence.
Learn about PMS monitoringSearch the 510(k) database now
Free to search. Create an account to save results and set up continuous monitoring.
Frequently Asked Questions
What is an FDA 510(k) clearance?
A 510(k) is a premarket submission to FDA demonstrating that a new medical device is substantially equivalent to a legally marketed predicate device. Clearance under Section 510(k) of the FD&C Act allows the device to be commercially distributed in the United States.
How do I search the FDA 510(k) database?
The FDA 510(k) database can be searched through the openFDA API (api.fda.gov/device/510k), the FDA CDRH 510(k) Premarket Notification Database, or third-party tools like TrueMedDevice that aggregate and structure the data for easier searching by product codes, applicant names, and decision dates.
What information does a 510(k) clearance record contain?
Each 510(k) record includes the K-number, applicant name, device name, product code, review panel, decision date, decision (SESE = substantially equivalent), clearance type (traditional, special, abbreviated), statement/summary, and the predicate device(s) referenced.
How can 510(k) data support post-market surveillance?
510(k) clearance data helps identify predicate devices, competitor products in your device category, and new entrants to your market. Monitoring new clearances in your product code can reveal technology trends, new indications for use, and potential predicate chains for future submissions.
How many 510(k) clearances are in the FDA database?
The FDA 510(k) database contains clearance records dating back to 1976. TrueMedDevice indexes these records along with other FDA and Health Canada regulatory data sources.
Also see: PMS Monitoring Tool · FDA Recall Monitoring · Try Free Demo