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.
Searcher, Mastoid
Ear, Nose, Throat
Searcher, Mastoid is a surgical probe or instrument used during mastoidectomy to explore and identify structures within the mastoid air cells, detect the presence of cholesteatoma or disease extension, and locate anatomical landmarks such as the facial nerve canal. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JZC, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.
No 510(k) clearances found for "JZC". 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.