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.
Material, External Aesthetic Restoration, Used With Adhesive
General, Plastic Surgery
The Material, External Aesthetic Restoration, Used With Adhesive (product code GBI) is an external prosthetic or restorative material adhered to the body surface to restore or simulate normal anatomical appearance, used in conjunction with a medical adhesive for patients who have undergone surgery or sustained tissue loss. It is classified as FDA Class 1, posing the lowest level of risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.3800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
510(k) Clearances
17 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.