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.
Facial Implant
General, Plastic Surgery
The Facial Implant (product code ODU) is a general and plastic surgery implant used in cosmetic augmentation and correction of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks, as part of plastic and reconstructive surgical procedures. The implants are typically made from biocompatible materials such as silicone elastomer or expanded polytetrafluoroethylene. This device is FDA Class 2 under regulation 878.3500 in the General, Plastic Surgery specialty, requires 510(k) clearance, and carries an implant flag indicating it is surgically placed in the body. It carries no life-sustaining flag.
510(k) Clearances
1 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.