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
Active Implantable Bone Conduction Hearing System
Ear, Nose, Throat
The Active Implantable Bone Conduction Hearing System is a prescription device comprising an implanted transducer, electronic components, and an external audio processor, intended to compensate for conductive or mixed hearing loss by transmitting amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. It is an FDA Class 2 device regulated under 21 CFR 874.3340, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is PFO, falling under the Ear, Nose, and Throat (EN) medical specialty. The device is flagged as an implant given its surgically placed transducer component.
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.