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.
Generator, Electronic Noise (For Audiometric Testing)
Ear, Nose, Throat
The electronic noise generator for audiometric testing is a device that produces calibrated masking noise used during audiometric evaluations to prevent the non-test ear from responding to test stimuli, ensuring accurate hearing threshold measurements. It is classified as FDA Class 2, indicating moderate risk, and is subject to special controls without requiring a traditional 510(k) for all configurations. The product code is ETS, regulated under 21 CFR 874.1120 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
510(k) Clearances
5 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.