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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Foot Wrap For Treating Restless Leg Syndrome Symptoms
Physical Medicine
The Foot Wrap for Treating Restless Leg Syndrome Symptoms (product code OTX) is a physical medicine device that applies compression to the muscles of the foot to affect nerve impulses sent to the central nervous system, providing relief from restless leg syndrome symptoms. It is a non-invasive, wearable wrap device designed for home or clinical use. As an FDA Class 1 device under regulation 890.5760, it is subject to general controls only, which is the lowest level of FDA regulatory oversight. It falls within the Physical Medicine specialty and is not an implant or life-sustaining device.
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.