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.
Hearing Aid, Group And Auditory Trainer
Ear, Nose, Throat
The group hearing aid and auditory trainer is a sound amplification system designed for use in group settings such as classrooms, intended to assist individuals with hearing impairment by amplifying sound and improving signal-to-noise ratio. It is classified as FDA Class 2, representing moderate risk, and requires 510(k) premarket clearance. The product code is EPF, regulated under 21 CFR 874.3320 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
510(k) Clearances
32 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.