# Premarket Search — FDA 510(k), PMA & recalls > Offline FDA 510(k) medical device database search and analysis tool. (iPhone/iPad app by Chris Carcerano.) - Source: https://appshunter.io/ios/app/premarket-search/id6787273566 (this page in markdown: same URL + `.md`) - Developer: [Chris Carcerano](https://appshunter.io/developer/383514160) - Category: Reference, Business - Price: Free - Rating: 5.00/5 from 1 App Store ratings - Age rating: 4+ - Requires: iOS 18.6 · 123 MB - Languages: American English - Released: 2026-07-06 - Data updated: 2026-08-15 - Monetization: free - User reviews in markdown: https://appshunter.io/ios/app/premarket-search/id6787273566/reviews.md ## What is Premarket Search? Premarket Search puts the U.S. FDA's medical device databases in your pocket — 175,000+ 510(k) clearances and 56,000+ PMA approvals, searchable in milliseconds, entirely offline. Built for regulatory affairs, device engineering, research, market analysis, and clinical practice. No account, no sign-in. THREE FDA PATHWAYS • 510(k) premarket notifications — 175,000+ cleared devices, bundled offline • PMA premarket approvals — 56,000+ Class III approvals and supplements, bundled offline • Device recalls — searched live against the FDA's public openFDA API (internet required) SEARCH INSTANTLY • Full-text search across the bundled dataset in milliseconds, with type-ahead matching • Find 510(k)s by device name, applicant company, contact, product code, or K-number • Find PMAs by trade name, generic name, applicant, or PMA number • Search recalls by firm, product, reason, root cause, product code, K-number, PMA number, or recall number • Choose which fields to search, and sort by relevance, date, company, or name • Every result shows the review time and how long ago the device was cleared STRUCTURED FILTERS (510(k)) • Narrow by review panel (medical specialty), product code, and submission type • Filter by decision outcome — substantially equivalent, De Novo, or other • Constrain decision or received dates and min/max review days • Filter third-party review and applicant state or country • Run filters alone or combine them with free-text search BROWSE BY CODE OR COMPANY • Explore 7,000+ product codes with device class, 21 CFR regulation, clearance count, latest decision, and average review time • Browse applicant companies and open a full clearance timeline for any firm • Jump from a product code or company straight into filtered search EVERY RECORD IN FULL • Device name, K-number or PMA number, and the clearance or approval decision • Applicant company, contact, and address; submission and decision dates; review time • Product code, review panel, submission type, and third-party review status • Open the official FDA summary PDF or the FDA device page inside the app LIVE openFDA CONTEXT (internet required) Every 510(k) and PMA record can pull public FDA context on demand: • Product-code classification — device class, regulation, implant and life-sustaining flags • Linked device recalls, with the full recall record in-app • High-level MAUDE adverse-event counts, with sample reports • FDA establishment registration & listing for the applicant, with Open in Maps • GUDID commercial device entries for the premarket number LIBRARY, COMPARE & EXPORT (510(k)) • Star favorites and organize named collections with personal notes • Revisit recent searches from on-device history • Compare up to four clearances side by side • Export results or full records as CSV, JSON, or Markdown STATISTICS • A dashboard of 510(k) trends over the last 1, 3, 6, 12, 18, or 24 months • Devices reviewed, average and median days to review, and the busiest month • Reviews-per-month and average-review-time charts • Submission-type mix, busiest specialties, De Novo count, and third-party share BUILT FOR SPEED & PRIVACY • 510(k), PMA, and product-code data search completely offline — the bundled dataset lives on your device • Recall search and the live context sections contact the FDA's public servers (api.fda.gov, accessdata.fda.gov). Those requests carry no account, identifier, or personal data • No analytics, no advertising, no tracking, and no data collection of any kind • Favorites, collections, and history never leave your device • Clean, modern design with full VoiceOver and Dynamic Type support 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), PMA, and device-classification files and from the public openFDA APIs, and is provided for informational purposes only. ## Key features - Full-text search of 175,000+ devices - Offline access to FDA clearance data - Device details including K-number and clearance - Applicant company and contact information - Submission and decision dates - Statistics and trends dashboard - View official FDA 510(k) summary PDFs ## Frequently asked questions about Premarket Search ### 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. ## Version history (last 3 releases) ### 2.2 — 2026-08-09 TWO NEW WAYS TO SEARCH • PMA approvals, offline — search 56,000+ Class III Premarket Approvals and supplements by trade name, generic name, applicant, or PMA number, with the full approval record: supplement type and reason, advisory committee, device class, regulation, and AO statement • Device recalls, live — search the FDA's public recall database by firm, product, reason, root cause, product code, K-number, PMA number, or recall number, and read the full recall record in-app (internet required) • Switch between 510(k), PMA, and Recalls right from the results list — each mode has its own search fields and sorting LIVE FDA CONTEXT ON EVERY RECORD (internet required) • Product-code classification — device class, 21 CFR regulation, implant and life-sustaining flags • Linked recalls and high-level MAUDE adverse-event counts, with sample reports • FDA establishment registration & listing for the applicant, with Open in Maps • GUDID commercial devices for the premarket number • Each section now loads independently, so one slow lookup no longer holds up the others SEARCH FIXES • Product Code is now its own 510(k) search field. Previously it only matched as a side effect of having every field switched on, so turning off an unrelated field silently dropped thousands of matches • Recall search now ranks the firm you actually typed first, and firm names containing "&" ("Smith & Nephew") return results instead of an error • Decision-date and date-received filters were off by one day for users east of UTC • A partly-typed search is no longer ignored when a filter is active • "Search this company" no longer permanently overwrites your saved search-field settings • Recent searches now restore the filters they were run with, and one typed phrase no longer fills history with half-typed entries BROWSE, LIBRARY & COMPARE • Company browse no longer splits the same firm into duplicate rows with mismatched counts • Browse lists now say when results are capped instead of showing a total that doesn't match • Product-code rows show device class and 21 CFR regulation number • You can remove a device from a collection again — swipe the row • Adding to Compare from Browse works, and tells you when the compare basket is full • Tapping a device in Browse reliably opens its record ACCESSIBILITY • VoiceOver reads each result as one clear sentence instead of fragment by fragment • Decision status now has its own icon, so it never depends on colour alone • Charts, browse rows, statistics cards, and identifiers stay readable at the largest text sizes • Higher-contrast detail text, labelled loading indicators, and bigger tap targets in the filter and compare bars PERFORMANCE & POLISH • Large exports, PDF sharing, and typing collection notes no longer freeze or stutter the app • Exported CSVs open safely in Excel and Numbers — text starting with =, + or - is no longer treated as a formula • On iPad, the detail pane no longer shows the previous device's record while the next one loads • FDA device pages that previously showed "Access Denied" now open in the in-app browser • Clearer empty states, including one for when recall search can't reach the FDA • About the data now lists 510(k), PMA, and product-code record counts and explains what works offline • Fresh FDA data with the latest clearances and approvals Thanks for using Premarket Search! Questions or ideas? Visit pocketfetch.com. ### 2.1.0 — 2026-07-07 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. ### 2.0.1 — 2026-07-06 No release notes. ## More apps by Chris Carcerano - [CAHA InfoCenter](https://appshunter.io/ios/app/caha-infocenter/id482995309) - [Fly Forecast](https://appshunter.io/ios/app/fly-forecast/id1467766730) - [CAHA States](https://appshunter.io/ios/app/caha-states/id1559053393) - [Ham Radio Companion](https://appshunter.io/ios/app/ham-radio-companion/id6784790696) - [Center Ice](https://appshunter.io/ios/app/center-ice/id6794094481) All apps by Chris Carcerano: https://appshunter.io/developer/383514160 --- *Data collected daily from the US App Store and indexed by [AppsHunter](https://appshunter.io/). User reviews are verbatim App Store reviews. Ratings, prices and chart positions refresh continuously; this snapshot is from 2026-08-15.*