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.
Metabolic Neuromodulation System
Unknown
The Metabolic Neuromodulation System is a novel device used to treat type 2 diabetes through hepatic nerve denervation, consisting of a monopolar single electrode ablation catheter and a radiofrequency generator intended to ablate the sympathetic nerves surrounding the common hepatic artery. It is classified as "Not Classified" (Class N) by the FDA, indicating it has not been assigned to an established classification category and may require a De Novo or novel regulatory pathway. The product code is PIK, reviewed by the Gastroenterology and Urology (GU) panel. This device is not implantable and is not life-sustaining.
No 510(k) clearances found for "PIK". 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.