# DEN240062: Minder System

- Pathway: De Novo (Direct)
- Applicant: Epi-Minder Pty, Ltd.
- Decided: Apr 17, 2025 after 181 days
- Product code: SEM (Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring)
- Device class: 2
- Regulation: 21 CFR 882.1360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K253607: UNEEG EpiSight System (2026), 0 descendants of its own

## Indications for use
The Minder System is an electroencephalographic (EEG) recording and transmitting device implanted under the scalp. It is a prescription device indicated to acquire, transmit, and store EEGs continuously from patients between 18-75 years of age with drug-resistant epilepsy who are intolerant or not indicated for more conservative monitoring tools. The Minder System is intended to aid in a physician's remote assessment and monitoring of the indicated patient’s condition. Remote patient assessment and monitoring for this use is defined as the patient’s EEG data is available for review by a healthcare provider located at a different location from the patient and where the data is being collected. The medical use of the data acquired by the Minder System is to be performed under the direction and interpretation of a licensed medical professional. The Minder System does not provide any diagnostic conclusions about the patient's condition.

Source page: https://510kreport.com/device/DEN240062
Methodology: https://510kreport.com/methodology