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.
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
General, Plastic Surgery
A noninflatable internal silicone gel-filled breast prosthesis is a surgically implanted device used for breast augmentation or reconstruction following mastectomy, filled with cohesive silicone gel. It is classified as FDA Class 3 (highest risk), requiring a Premarket Approval (PMA) application, reflecting its status as a permanent implant with significant safety considerations. The product code is FTR, regulated under 21 CFR 878.3540, within the General, Plastic Surgery medical specialty; a call for PMAs was issued per 56 FR 14627 on April 10, 1991. This device is designated as an implant.
No 510(k) clearances found for "FTR". 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.