Premarket Search
FDA 510(k) device lookup
About
Quickly search and explore over 175,000 FDA 510(k) cleared medical devices. Access detailed information, statistics, and insights offline. Ideal for professionals and researchers in the medical device industry.
What's New in Premarket Search
2.1.0
July 7, 2026
STATISTICS DASHBOARD Tap the chart button to open a brand-new Statistics view: • Total devices reviewed, plus average and median days to review • Choose a range — last 1, 3, 6, 12, 18, or 24 months • Reviews-per-month and average-review-time charts • A breakdown of submission types and the top medical specialties • De Novo authorizations, third-party review share, and the busiest month SHARPER RESULTS • Each search result now shows how long the review took and how long ago the device was cleared • Cleaner, faster list and detail layouts FRESH DATA • Refreshed with the latest FDA 510(k) clearances FIXES • Clearance dates now display correctly in every time zone Thanks for using Premarket Search! Questions or ideas? Visit pocketfetch.com.
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FAQ
What is Premarket Search?
Premarket Search is a mobile application that provides offline access to the U.S. FDA's 510(k) premarket notification database. It allows users to search and explore over 175,000 cleared medical devices with detailed information.
Does Premarket Search have ads?
No, Premarket Search is ad-free. The app explicitly states it has no ads, ensuring an uninterrupted user experience.
What devices is Premarket Search available on?
Premarket Search is available on iPhone and iPad devices. It features a clean, modern design that adapts well to both screen sizes.
How often is Premarket Search updated?
The latest version of Premarket Search is 2.1.0, which was last updated on July 7, 2026. While specific update frequency isn't detailed, this indicates recent development activity.
Can I use Premarket Search offline?
Yes, Premarket Search is designed for offline use. The entire dataset of over 175,000 devices lives on your device, allowing you to search and browse without an internet connection.
Is there a cost to use Premarket Search?
No, Premarket Search is completely free to use. There are no charges associated with downloading or accessing its features.
What kind of data can I find in Premarket Search?
You can find comprehensive data for each cleared medical device, including the device name, K-number, applicant company, submission and decision dates, review time, product code, and the official FDA 510(k) summary PDF.
What are the statistics and insights offered by Premarket Search?
Premarket Search provides a dashboard with statistics such as total devices reviewed, average and median review days, reviews-per-month charts, submission-type mix, and busiest medical specialties, all filterable by time range.