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.
Wound Retraction And Protection System
General, Plastic Surgery
The Wound Retraction and Protection System is a prescription surgical device used by surgeons to retract the surgical incision, provide access to the surgical wound, protect and irrigate the wound, and serve as a conduit for removing fluid from the wound during open surgery. It is classified as FDA Class 2 under 21 CFR 878.4371 in the General and Plastic Surgery specialty, requiring 510(k) clearance. The device is eligible for third-party 510(k) review. Product code PQI; not an implant and not life-sustaining.
510(k) Clearances
2 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.