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.
Cystotome
Ophthalmic
A Cystotome is a fine ophthalmic surgical instrument with a small hook or needle tip used to create an opening in the anterior lens capsule during cataract surgery, enabling removal of the lens nucleus and cortex while preserving the capsular bag for lens implant placement. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket submission. It carries product code HNY and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
510(k) Clearances
20 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.