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.
Lens, Iris Reconstruction
Ophthalmic
The Iris Reconstruction Lens is an intraocular lens (IOL) used in patients with partial or complete loss of the iris due to trauma or congenital defect, serving as both an artificial iris and lens to reduce light sensitivity and/or glare disability, and implanted in the capsular bag or sulcus for correction of aphakia and aniridia. It is classified as FDA Class 3 (Premarket Approval), requiring PMA approval, under product code NIZ and regulation 21 CFR 886.3600 in the Ophthalmic specialty. The device is flagged as an implant and is not life-sustaining.
No 510(k) clearances found for "NIZ". 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.