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
Medical Computers And Software For Ophthalmic Use
Unknown
Medical computers and software for ophthalmic use are electronic systems and associated software specifically designed to assist in the diagnosis, management, or treatment of ophthalmic conditions, including image analysis, diagnostic decision support, or device control in an ophthalmology setting. They are classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) given the potential for patient harm if the software produces erroneous diagnostic output or fails to operate correctly. The product code is LQB; no regulation number or specific medical specialty code is listed for this entry. No special flags apply to this device.
510(k) Clearances
2 matchesWhat 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.