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
Intraocular Pressure Lowering Implant
Unknown
The Intraocular Pressure Lowering Implant is a surgically implanted device intended to reduce intraocular pressure in eyes that have not responded to conventional medical and surgical treatment, typically used in refractory glaucoma. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA) due to the significant risk associated with an implanted device in the eye that supports critical physiological functions. The product code is OGO, reviewed by the Ophthalmic panel; no specific regulation number has been assigned. It carries an implant flag indicating permanent or semi-permanent placement within the body.
No 510(k) clearances found for "OGO". 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.