# 510(k)Explorer — Fast FDA 510k Predicate Chains

> Fast FDA 510k Predicate Chains (iPhone/iPad app by Abel Swaan.)

- Source: https://appshunter.io/ios/app/510kexplorer/id6759165352 (this page in markdown: same URL + `.md`)
- Developer: [Abel Swaan](https://appshunter.io/developer/1842903934)
- Category: Business, Productivity
- Price: $7.99
- Age rating: 4+
- Requires: iOS 26.2 · 64 MB
- Languages: American English
- Released: 2026-05-22
- Data updated: 2026-06-02

## What is 510(k)Explorer?

Navigate the FDA 510(k) predicate chain like never before.

510(k) Predicate Explorer gives regulatory professionals, consultants, and device makers a fast, visual way to research substantial equivalence. Search across 99,000+ FDA clearances and instantly map how any device traces back through its predicate history — spanning decades and product generations.

SEARCH
Find any cleared device by K-number, device name, or company. Results are ranked newest first, so the most relevant clearances surface immediately.

GRAPH VIEW
Explore predicate relationships as an interactive network. Drag nodes, pinch to zoom, and tap any device to see its clearance details, indications for use, and which other devices cite it as a predicate.

TIMELINE VIEW
See the full predicate lineage plotted on a proportional time axis. Each generation of predicates appears in its own row, positioned by the actual year of clearance — so a chain spanning 1987 to 2024 tells its story at a glance. Ideal for spotting decade-long lineages, identifying technological turning points, and understanding how a device family evolved.

DEVICE DETAILS
For every node in the graph or timeline: K-number, device name, applicant, indications for use, full predicate list, and a list of all later devices that cited it. One tap opens the official FDA 510(k) summary PDF.

ALWAYS CURRENT
Refresh directly from the FDA database to pull in the latest clearances. The bundled dataset covers all submissions on record; the refresh adds new entries as they are cleared.

WHO IT'S FOR
• Regulatory affairs professionals building 510(k) submissions
• RA consultants benchmarking predicate strategies
• Medical device companies scoping competitive landscape
• Investors conducting regulatory due diligence
• Researchers studying the history of medical device clearances

## Is 510(k)Explorer safe?

Not enough ratings yet to assess 510(k)Explorer.

## Is 510(k)Explorer legit?

510(k)Explorer has limited verification signals. The AppsHunter Legitimacy Score for 510(k)Explorer is 48 out of 100 points across 7 verification signals from App Store and developer data.


## Version history (last 2 releases)

### 1.1 — 2026-05-26

Updates and adds disclaimer. Because the 510k data is retrieved with a scrapper, the data is perfect for a fast glance but should always be checked.
The 510K data will be updated regularly.

### 1.0 — 2026-05-22

No release notes.

## More apps by Abel Swaan

- [Check these Bricks](https://appshunter.io/ios/app/check-these-bricks/id6753183821)

All apps by Abel Swaan: https://appshunter.io/developer/1842903934

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*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 2026-06-02.*