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.
Trocar, Ent
Ear, Nose, Throat
This device is an ENT trocar, a sharp or blunt-tipped instrument used in ear, nose, and throat surgery to create an access port or puncture through tissue, such as the nasal sinuses, to facilitate drainage or the passage of surgical instruments. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KTE, regulated under 21 CFR 874.4420 within the Ear, Nose, and Throat specialty. No special flags apply.
510(k) Clearances
1 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.