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.
Syringe, Piston, Reprocessed
General Hospital
The Reprocessed Piston Syringe is a reprocessed version of a standard piston syringe, consisting of a calibrated hollow barrel and movable plunger with a male connector at one end for attachment to a hypodermic needle, used to inject fluids into or withdraw fluids from the body; reprocessing validation data must be included in the 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NKN and regulation 21 CFR 880.5860 in the General Hospital specialty. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "NKN". Try a different K-number, product code, or device name.
What 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.