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.
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Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Unknown
The Cochlear Implant with Combined Electrical Stimulation and Acoustic Amplification is an advanced hearing implant intended to provide electrical stimulation to the mid-to-high frequency cochlear region while also delivering acoustic amplification to residual low-frequency hearing regions, for patients with partial hearing loss. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to its high-risk implantable nature, reviewed by the Ear, Nose, and Throat (EN) panel. The product code is PGQ, and the device is flagged as an implant. No regulation number has been assigned.
No 510(k) clearances found for "PGQ". Try a different K-number, product code, or device name.
What 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.