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.
Applicator, Absorbent Tipped, Non-Sterile
General Hospital
The Non-Sterile Absorbent Tipped Applicator is a general-purpose medical applicator with an absorbent tip, such as cotton or foam, used for applying medications, cleansing wounds, or collecting specimens in a non-sterile configuration. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KXF, regulated under 21 CFR 880.6025, in the General Hospital medical specialty. This device is GMP exempt.
510(k) Clearances
21 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.