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.
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Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Ear, Nose, Throat
The Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus is a device that delivers both acoustic stimulation in the ear and external electrical stimulation of sensory nerves simultaneously to provide relief from tinnitus, leveraging multimodal neuromodulation to address the central and peripheral components of tinnitus perception. Classified as FDA Class 2 under regulation 874.3410, it requires 510(k) clearance in the Ear, Nose, and Throat specialty. It is not an implant and not life-sustaining.
510(k) Clearances
1 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.