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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Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
General, Plastic Surgery
The Negative Pressure Wound Therapy Device For Reduction Of Wound Complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure, removing wound exudate, irrigation fluids, and infectious materials; it is intended for use with wound dressings classified under 21 CFR 878.4780 and does not include devices for organ space wounds. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 878.4783 in the General and Plastic Surgery specialty. The product code is QFC. It is not an implant and is not life-sustaining.
510(k) Clearances
3 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.