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
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Neurology
A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription neurological device used to continuously acquire, transmit, and store electrical brain activity in patients with epilepsy via sub-scalp implanted electrodes connected to a transmitter or storage device, enabling remote clinician monitoring of brain activity between visits; it is not intended to be implanted in brain tissue. It is classified as FDA Class II (510(k) required) under regulation 882.1360 in the Neurology specialty, with product code SEM. The device is flagged as an implant due to the sub-scalp electrode placement, but does not support life-sustaining functions.
510(k) Clearances
2 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.