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.
Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
General, Plastic Surgery
The Negative Pressure Wound Therapy Non-Powered Suction Pump (Chemical) is a wound management device that applies continual or intermittent negative pressure to wounds for the removal of fluids including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers, flaps, and grafts. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4683 in the General and Plastic Surgery specialty. It carries product code QPX and is not an implant and not life-sustaining.
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.