A look inside
About Premarket Search
Premarket Search is the fastest way to explore the U.S. FDA's 510(k) premarket notification database — more than 175,000 cleared medical devices — right from your iPhone or iPad.
Whether you work in regulatory affairs, engineer medical devices, conduct research, analyze the market, or practice medicine, Premarket Search puts decades of FDA clearance data at your fingertips. Search and browse everything offline, with no account and no sign-in.
Search instantly
- Full-text search across 175,000+ devices in milliseconds
- Find devices by name, applicant company, contact, or K-number
- Smart type-ahead matching as you type
- Choose which fields to search, and sort by relevance, decision date, company, or device name
- Every result shows the review time and how long ago the device was cleared
Every clearance detail
- Device name, K-number, and clearance decision
- Applicant company, contact, and address
- Submission and decision dates, plus total review time
- Product code, review panel, submission type, and third-party review status
- Open the official FDA 510(k) summary PDF right inside the app
Statistics & insights
A dashboard that turns the raw data into trends at a glance:
- Pick a range — last 1, 3, 6, 12, 18, or 24 months
- Total devices reviewed, plus average and median days to review
- Reviews-per-month and average-review-time charts
- Submission-type mix and the busiest medical specialties
- De Novo authorizations, third-party review share, and the busiest month
Built for speed
- Powered by a full-text search index for near-instant results
- Search and browse completely offline — the entire dataset lives on your device
- No account, no sign-in, no tracking, no ads
- Clean, modern design that adapts beautifully across iPhone and iPad
Who it's for
- Regulatory affairs and quality professionals researching predicate devices
- Medical device engineers and product teams
- Investors and analysts tracking clearances and competitors
- Clinicians, researchers, students, and the simply curious
Disclaimer: Premarket Search is not affiliated with, sponsored by, or endorsed by the U.S. Food and Drug Administration. All data is sourced from the FDA's publicly available 510(k) files and is provided for informational purposes only.
