510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Over-The-Counter Automated External Defibrillator
Cardiovascular
The Over-The-Counter Automated External Defibrillator (AED) is a consumer-accessible device that uses external pad-type electrodes to detect and treat ventricular fibrillation in suspected victims of sudden cardiac arrest by delivering an electrical shock. It is approved for use without a prescription on adults and children over 8 years old or over 55 pounds who are unresponsive and not breathing normally. As an FDA Class 3 device regulated under 21 CFR 870.5310, it requires Premarket Approval (PMA) given its life-sustaining and high-risk nature. The product code is NSA, falling within the Cardiovascular specialty. This device is flagged as life-sustaining, reflecting its critical role in emergency resuscitation.
510(k) Clearances
1 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.