# K203827: REMI

- Pathway: 510(k) (Traditional)
- Applicant: Epitel, Inc.
- Decided: Mar 29, 2021 after 90 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830295 (1983). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171459: Ceribell Instant EEG Headband, Ceribell, Inc. (2017) Summary page 5.
- K170363: Ceribell Pocket EEG Device, Ceribell, Inc. (2017) Summary page 5.
- K183529: AE-120A EEG Head Set, Nihon Kohden Corporation (2019) Summary page 7.

## Most influential descendants
- K230933: REMI Remote EEG Monitoring System (2023), 1 descendant of its own
- K243185: REMI Remote EEG Monitoring System (2025), 0 descendants of its own
- K223628: NEBA® Compact EEG2R Mobile Headset (2023), 0 descendants of its own

## Indications for use
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors — a single use, single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software. REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professionals in a professional healthcare facility environment. Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).

Source page: https://510kreport.com/device/K203827
Methodology: https://510kreport.com/methodology