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.
Refractive Corneal Implant
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The Refractive Corneal Implant (product code ODK) is an ophthalmic implant intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus, with the goal of restoring functional vision and potentially deferring the need for corneal transplantation. The device is surgically implanted within the cornea to alter its refractive properties. It has a device class of "f," indicating marketing authorization through a humanitarian device exemption (HDE) or similar pathway, and carries an implant flag; it has no assigned regulation number or medical specialty code.
No 510(k) clearances found for "ODK". 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.