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.
Euthyscope, Ac-Powered
Ophthalmic
The AC-Powered Euthyscope is an electrically powered ophthalmic device that projects a bright light with a central disc occluder onto the retina, used in the diagnosis and treatment of eccentric fixation associated with amblyopia, helping to determine the location of the preferred retinal locus. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is HMK, regulated under 21 CFR 886.1250, within the Ophthalmic medical specialty. No special risk flags apply to this device.
No 510(k) clearances found for "HMK". 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.