# K253607: UNEEG EpiSight System

- Pathway: 510(k) (Traditional)
- Applicant: Uneeg Medical A/S
- Decided: Jun 11, 2026 after 205 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
Longest line of descent: 1 generation back to DEN240062 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240062: Minder System, Epi-Minder Pty, Ltd. (2025) Summary page 5.

## Indications for use
The UNEEG EpiSight System is an electroencephalographic (EEG) recording and transmitting device system with a subcutaneous implant. It is indicated for continuous EEG recording in patients aged 18 and older with uncontrolled epilepsy. The UNEEG EpiSight System is a prescription device intended to aid in physician’s remote assessment and monitoring of the patient’s condition. Remote assessment and monitoring are defined as the availability of EEG data for review by a healthcare provider located at a different location from where the data is being collected. The medical use of the data acquired by the UNEEG EpiSight System is to be performed under the direction and interpretation of a licensed medical professional. The device does not provide diagnostic conclusions regarding the patient’s condition.

Source page: https://510kreport.com/device/K253607
Methodology: https://510kreport.com/methodology