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.
Stimulator, Thalamic, Epilepsy, Implanted
Unknown
The implanted thalamic stimulator for epilepsy is a surgically placed neurostimulation device designed to deliver electrical stimulation to the thalamus to reduce seizure frequency or severity in patients with refractory epilepsy. It is classified as FDA Class III, requiring Premarket Approval (PMA) with rigorous clinical evidence of safety and effectiveness. The product code is MBX and no regulation number or formal medical specialty has been assigned. The device carries an implant flag reflecting its surgical placement within the brain.
No 510(k) clearances found for "MBX". 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.