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, Bone Conduction, Implanted
Ear, Nose, Throat
The implanted bone conduction hearing aid is a surgically placed device within the Ear, Nose, Throat specialty that transmits sound vibrations through bone directly to the inner ear, bypassing the outer and middle ear. It is classified as FDA Class II, meaning manufacturers must demonstrate substantial equivalence to a predicate device through a 510(k) premarket notification before marketing. The product code is MAH and it is regulated under 21 CFR 874.3302. This device carries an implant flag, indicating it is surgically placed inside the body, and is not GMP-exempt, requiring full quality system regulation compliance.
510(k) Clearances
11 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.