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.
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Neurology
The Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine is a device intended to treat headache through the application of electrical stimulation on the body of the patient, specifically anywhere apart from the head or neck, through electrodes placed on the skin (transcutaneously or percutaneously), for acute migraine treatment. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.5899 in the Neurology specialty. The product code is QGT. It is not an implant and is not life-sustaining.
510(k) Clearances
7 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.