OMC · Class II · 21 CFR 882.1400

FDA Product Code OMC: Reduced- Montage Standard Electroencephalograph

Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes

Leading manufacturers include Cleveland Medical Devices, Inc., Advanced Brain Monitoring, Inc. and Forest Devices, Inc..

28
Total
28
Cleared
143d
Avg days
1978
Since
Growing category - 5 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 180d recently vs 135d historically

FDA 510(k) Cleared Reduced- Montage Standard Electroencephalograph Devices (Product Code OMC)

28 devices
1–24 of 28
Cleared Nov 25, 2025
NX01 (NX01)
K251550
Naox Technologies Sas
Neurology · 188d
Cleared Sep 03, 2025
SignalNED System (Model RE)
K251726
Forest Devices, Inc.
Neurology · 90d
Cleared Mar 21, 2025
REMI Remote EEG Monitoring System
K243185
Epitel
Neurology · 172d
Cleared Nov 19, 2024
Natus BrainWatch System
K242930
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 56d
Cleared Oct 11, 2024
QUEX ED
K232779
Qx World, Ltd.
Neurology · 396d
Cleared Sep 04, 2024
SignalNED System (Model RE)
K242306
Forest Devices, Inc.
Neurology · 30d
Cleared Jun 30, 2023
REMI Remote EEG Monitoring System
K230933
Epitel, Inc.
Neurology · 88d
Cleared Mar 02, 2023
NEBA® Compact EEG2R Mobile Headset
K223628
Neba Health, LLC
Neurology · 87d
Cleared Oct 24, 2022
Neurosteer EEG Recorder
K221563
Neurosteer, Inc.
Neurology · 146d
Cleared Mar 29, 2021
REMI
K203827
Epitel, Inc.
Neurology · 90d
Cleared Jun 22, 2020
Byteflies Kit
K192549
Byteflies NV
Neurology · 279d
Cleared Mar 19, 2019
AE-120A EEG Head Set
K183529
Nihon Kohden Corporation
Neurology · 90d
Cleared May 08, 2017
Ceribell Pocket EEG Device
K170363
Ceribell, Inc.
Neurology · 91d
Cleared Oct 30, 2015
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
K152040
Advanced Brain Monitoring, Inc.
Neurology · 100d
Cleared Apr 10, 2014
IEEG
K131944
Jordan Neuroscience, Inc.
Neurology · 287d
Cleared Jan 31, 2013
X4 SYSTEM
K130013
Advanced Brain Monitoring, Inc.
Neurology · 29d
Cleared Jun 20, 2012
X4
K120447
Advanced Brain Monitoring, Inc.
Neurology · 127d
Cleared Jun 30, 2011
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967
Neuralynx, Inc.
Neurology · 85d
Cleared Oct 29, 2010
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
K092477
Neurowave Systems, Inc.
Neurology · 443d
Cleared Mar 28, 2006
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
K060523
Cyberkinetics, Inc.
Neurology · 29d
Cleared Sep 08, 2004
BIOSOMNIA-V3
K042309
Oxford Biosignals Limited
Neurology · 14d
Cleared May 10, 2004
ENVOY PATIENT MONITOR
K024245
Mennen Medical , Ltd.
Neurology · 504d
Cleared Sep 11, 2002
BIOSOMNIA
K021485
Oxford Biosignals Limited
Neurology · 126d
Cleared Jun 18, 2002
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335
Olympic Medical Corp.
Neurology · 137d

About Product Code OMC - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code OMC since 1978, with 28 receiving FDA clearance (average review time: 143 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OMC Product Code

Recent submissions under OMC have taken an average of 180 days to reach a decision - up from 135 days historically. Manufacturers should account for longer review timelines in current project planning.

OMC devices are reviewed by the Neurology panel. Browse all Neurology devices →