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.
Chamber, Oxygen, Topical, Extremity
General, Plastic Surgery
This device is a topical oxygen chamber designed to enclose an extremity and deliver concentrated oxygen directly to the wound surface, used to promote healing in chronic or non-healing wounds of the limbs. It is classified as FDA Class 2, indicating moderate risk, requiring 510(k) premarket notification. The product code is KPJ, regulated under 21 CFR 878.5650 within the General and Plastic Surgery specialty. No special flags apply.
510(k) Clearances
23 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.