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.
Topographer, Corneal, Battery Powered
Ophthalmic
The battery-powered corneal topographer is an ophthalmic device used to map the surface curvature of the cornea, aiding in the diagnosis of corneal disorders such as keratoconus and in the fitting of contact lenses or planning of refractive surgery. It is classified as FDA Class 1 under regulation 886.1350 in the Ophthalmic specialty, and it is GMP exempt. Product code NOG does not require a 510(k) submission and represents a battery-powered variant of the standard corneal topographer.
No 510(k) clearances found for "NOG". 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.