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.
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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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Adhesive Backed Thermal Skin Patches
Physical Medicine
The Adhesive Backed Thermal Skin Patches (product code OMW) are Class 1 devices regulated under 21 CFR 890.5710 in the Physical Medicine specialty (PM), exempt from premarket notification. These over-the-counter heat patches are intended for temporary relief of muscular and joint pain associated with arthritis, backache, muscle strains, and sprains, and are applied directly to intact skin for up to 8 hours but no more than once per 24-hour period. The device is not an implant or life-sustaining, and should not be used on damaged skin, in children under 12, or by persons unable to perceive pain.
No 510(k) clearances found for "OMW". Try a different K-number, product code, or device name.
What 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.