# Epitel, Inc.

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 5 (2021–2025): 5 510(k) clearances
- Names in FDA's records: Epitel, Inc. (4); Epitel (1)
- Product codes: OMC (3), OMB (2)
- 510(k) review time since 2016: median 201 days, against 201 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ceribell, Inc.: 3 (https://510kreport.com/company/ceribell)
- Persyst Development Corporation: 1 (https://510kreport.com/company/persyst-development)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)

## Firms that cite its devices most
- Neba Health, LLC: 1 (https://510kreport.com/company/neba-health)

## Its most-cited devices
- K203827: REMI (2021), cited by 2
- K231779: REMI AI Discrete Detection Module (2024), cited by 1
- K230933: REMI Remote EEG Monitoring System (2023), cited by 1

## Recent decisions
- K243185: REMI Remote EEG Monitoring System (Mar 21, 2025)
- K240408: REMI-AI Rapid Detection Module (REMI-AI RDM) (Oct 17, 2024)
- K231779: REMI AI Discrete Detection Module (Jan 3, 2024)
- K230933: REMI Remote EEG Monitoring System (Jun 30, 2023)
- K203827: REMI (Mar 29, 2021)

Source page: https://510kreport.com/company/epitel