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
System, Ablation, Ultrasound And Accessories
General, Plastic Surgery
The Ultrasound Ablation System and Accessories is a surgical tool intended for the coagulation and ablation of soft tissue using high-intensity focused ultrasound energy, distinguishing it from electrosurgical devices and from tissue-cutting instruments. It does not cut tissue but rather delivers ultrasound energy for coagulation and ablation purposes. This is an FDA Class 2 device regulated under 21 CFR 878.4400 in the General and Plastic Surgery specialty, with product code NTB, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
6 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.