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 Cleaner, Ultrasound
General, Plastic Surgery
The Ultrasound Wound Cleaner is a device that delivers a cleaning fluid to a wound pulsed using low-power ultrasound radiation, intended to clean and mildly debride wounds. The ultrasound generator delivers 1.0 mW/cm2 or less energy to the wound, keeping the energy level low for safe wound management. It is an FDA Class 2 device under 21 CFR 878.4410, requiring 510(k) clearance, and falls within the General and Plastic Surgery specialty with product code NRB. The device is eligible for third-party 510(k) review. It is not an implant and does not provide life-sustaining support.
510(k) Clearances
9 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.