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, Contact (Rigid Gas Permeable), Extended Wear
Ophthalmic
An Extended Wear Rigid Gas Permeable Contact Lens is a contact lens made from oxygen-permeable rigid materials, approved for continuous overnight or extended wear for multiple days, used to correct refractive errors including myopia, hyperopia, and astigmatism. It is classified as FDA Class 3, requiring PMA approval due to the higher risk associated with extended overnight wear, with product code MWL under 21 CFR 886.5916 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "MWL". 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.