SEM · Class II · 21 CFR 882.1360

FDA Product Code SEM: Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring

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.

Leading manufacturers include Epi-Minder Pty, Ltd..

1
Total
0
Cleared
181d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring Devices (Product Code SEM)

1 devices
1–1 of 1
Not Cleared Apr 17, 2025
Minder System
DEN240062
Epi-Minder Pty, Ltd.
Neurology · 181d

About Product Code SEM - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SEM since 2025, with 0 receiving FDA clearance (average review time: 181 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SEM devices are reviewed by the Neurology panel. Browse all Neurology devices →