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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Lens, Contact, Orthokeratology, Overnight
Ophthalmic
The Overnight Orthokeratology Contact Lens is a rigid contact lens worn overnight to temporarily reduce myopia or other refractive errors through controlled corneal reshaping, allowing improved unaided vision during the day. This lens type involves overnight corneal contact, raising safety considerations that require the most stringent regulatory review. As an FDA Class 3 device regulated under 21 CFR 886.5916 in the Ophthalmic specialty, it requires Premarket Approval (PMA). The product code is NUU. It is not an implant and does not carry life-sustaining support designation.
No 510(k) clearances found for "NUU". 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.