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.
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Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Physical Medicine
The Nonthermal Shortwave Therapy Device is an over-the-counter device that uses nonthermal pulsed electromagnetic energy for the treatment of pain in the Physical Medicine specialty. It is classified as FDA Class 2 under 21 CFR 890.5290, requiring 510(k) premarket notification, and is available for consumer use without a prescription. The device delivers electromagnetic fields to targeted tissue areas to provide pain relief. Product code PQY; not an implant and not life-sustaining.
510(k) Clearances
2 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.