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.
Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
Neurology
The Reprocessed Manual Neurological Drills, Burrs, Trephines and Accessories are reprocessed manual neurosurgical instruments used for cutting, drilling, or removing bone during cranial and neurosurgical procedures; reprocessing validation data must be included in a 510(k) submission. They are classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLO and regulation 21 CFR 882.4300 in the Neurology specialty. The devices are eligible for third-party review and carry no implant or life-sustaining flags.
No 510(k) clearances found for "NLO". 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.