# K231779: REMI AI Discrete Detection Module

- Pathway: 510(k) (Traditional)
- Applicant: Epitel, Inc.
- Decided: Jan 3, 2024 after 201 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage 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: 1 generation back to K182181 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182181: Persyst 14 EEG Review and Analysis Software, Persyst Development Corporation (2018) Summary page 5.

## Most influential descendants
- K240408: REMI-AI Rapid Detection Module (REMI-AI RDM) (2024), 0 descendants of its own

## Indications for use
The REMI-AI Discrete Detection Module (REMI-AI DDM) is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI-AI DDM is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information. As an aide to the qualified physician’s REMI EEG review, REMI-AI DDM marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI-AI DDM is indicated for use with adult and pediatric patients (6+ years). REMI-AI DDM does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient's condition to the user.

Source page: https://510kreport.com/device/K231779
Methodology: https://510kreport.com/methodology