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
Prosthesis, Adhesive, External
General, Plastic Surgery
The Prosthesis, Adhesive, External (product code GBJ) is a non-implanted external prosthetic device that is attached to the body using medical adhesive, intended to replace or restore missing anatomical structures such as ears, noses, or other external features following surgery or trauma. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.3750 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
510(k) Clearances
4 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.