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.
Phakic Toric Intraocular Lens
Ophthalmic
The Phakic Toric Intraocular Lens is an implantable ophthalmic device intended to be placed within the eye to optically correct astigmatism, with or without other refractive errors, without removing the natural crystalline lens. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high risks associated with implantation in the eye and the need to demonstrate safety and effectiveness. The product code is QCB under regulation 886.3600 in the Ophthalmic specialty. This device carries an implant flag.
No 510(k) clearances found for "QCB". 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.