Premarket Search

FDA 510(k) device lookup

Free · Designed for iPad. Not verified for macOS.

New: a Statistics dashboard with clearance trends, average review times, and charts. Plus instant, offline search of 175,000+ FDA 510(k)-cleared medical devices. 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 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.

Ratings & Reviews

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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.

Version 2.1.0

The developer, Chris Carcerano, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .

  • Data Not Collected

    The developer does not collect any data from this app.

    Privacy practices may vary based, for example, on the features you use or your age. Learn More

    Accessibility

    The developer has not yet indicated which accessibility features this app supports. Learn More

    Information

    Provider
    • Chris Carcerano
    Size
    • 79.4 MB
    Category
    • Reference
    Compatibility
    Requires iOS 18.6 or later.
    • iPhone
      Requires iOS 18.6 or later.
    • iPad
      Requires iPadOS 18.6 or later.
    • Mac
      Requires macOS 15.6 or later and a Mac with Apple M1 chip or later.
    • Apple Vision
      Requires visionOS 2.6 or later.
    Languages
    • English
    Age Rating
    4+
    Copyright
    • © 2026 PocketFetch. All rights reserved.
  • Developer Website
  • Privacy Policy

    • More by Chris Carcerano