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.
Apparatus, Vestibular Analysis
Unknown
The Vestibular Analysis Apparatus (product code LXV) is a diagnostic device used to evaluate the function of the vestibular system of the inner ear, assisting in diagnosing conditions such as vertigo, dizziness, and balance disorders. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Ear, Nose, Throat (EN) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
22 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.