DeviceClearance

Product code SEM— Neurology

Minder System

Classification name
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Device class
Class 2
Regulation
21 CFR 882.1360
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patient’s brain. The device is not intended to be implanted in brain tissue.”

— U.S. Food and Drug Administration, device classification record for product code SEM under 21 CFR 882.1360, via openFDA

Market context for product code SEM

FDA has cleared 2 devices under product code SEM between 2025 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SEM

Recent clearances under product code SEM

Data sourced from openFDA. This site is unofficial and independent of the FDA.