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.
Free to try · every answer cites its records
Hearing Aid, Air Conduction, Transcutaneous System
Ear, Nose, Throat
The Transcutaneous Air Conduction Hearing Aid System is a wearable sound-amplifying device intended to compensate for impaired hearing, consisting of an air conduction hearing aid attached to a surgically fitted tube system that creates an air channel through soft tissue between the outer ear canal and the post-auricular region, transmitting amplified sound to the ear canal without occluding it. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIX and regulation 21 CFR 874.3950 in the Ear, Nose, and Throat specialty. Notably, the device is flagged as an implant due to the surgically fitted tube component, though it is 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.