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.
Device For Sleep Apnea Testing Based On Mandibular Movement
Ear, Nose, Throat
The Device for Sleep Apnea Testing Based on Mandibular Movement is a prescription device that aids in the evaluation of sleep apnea by analyzing sensor readings of mandibular (jaw) movement during sleep, identifying patterns associated with sleep-disordered breathing in patients suspected of having obstructive sleep apnea. It is not intended as a substitute for full polysomnography and must not be used as an apnea monitor. Classified as FDA Class 2 under regulation 868.2376, it requires 510(k) clearance and is reviewed under Anesthesiology with an Ear, Nose, and Throat specialty designation. It is not an implant and not life-sustaining.
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.