FDA Product Code OMB: Automatic Event Detection Software For Full-montage Electroencephalograph
Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
Leading manufacturers include Ceribell, Inc., Persyst Development Corporation and Ait Austrian Institute of Technology GmbH.
42
Total
42
Cleared
157d
Avg days
1987
Since
Growing category -
9 submissions in the last 2 years
vs 5 in the prior period
Consistent review times:
173d avg (recent)
FDA 510(k) Cleared Automatic Event Detection Software For Full-montage Electroencephalograph Devices (Product Code OMB)
42 devices
Cleared
Nov 21, 2025
Ceribell Infant Seizure Detection Software
Ceribell, Inc.
Neurology
143d
Cleared
Oct 31, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Persyst Development, LLC
Neurology
113d
Cleared
Apr 09, 2025
Ceribell Seizure Detection Software
Ceribell, Inc.
Neurology
310d
Cleared
Apr 09, 2025
autoSCORE (V 2.0.0)
Holberg Eeg AS
Neurology
126d
Cleared
Jan 22, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Persyst Development Corporation
Neurology
159d
Cleared
Nov 26, 2024
NeuroMatch
LVIS Corporation
Neurology
195d
Cleared
Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
Epitel, Inc.
Neurology
251d
Cleared
Sep 27, 2024
encevis (2.1)
Ait Austrian Institute of Technology GmbH
Neurology
169d
Cleared
Jan 07, 2024
autoSCORE
Holberg Eeg AS
Neurology
268d
Cleared
Jan 03, 2024
REMI AI Discrete Detection Module
Epitel, Inc.
Neurology
201d
Cleared
Jun 09, 2023
LVIS NeuroMatch
LVIS Corporation
Neurology
298d
Cleared
May 23, 2023
Ceribell Status Epilepticus Monitor
Ceribell, Inc.
Neurology
182d
Cleared
Dec 30, 2022
Persyst 15 EEG Review and Analysis Software
Persyst Development Corporation
Neurology
176d
Cleared
Dec 02, 2021
Encevis
Austrian Institute of Technology GmbH
Neurology
206d
Cleared
May 18, 2020
Natus NeuroWorks
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology
46d
Cleared
Sep 11, 2019
Ceribell Pocket EEG Device
Ceribell, Inc.
Neurology
120d
Cleared
Nov 29, 2018
Persyst 14 EEG Review and Analysis Software
Persyst Development Corporation
Neurology
108d
Cleared
Apr 19, 2018
encevis
Ait Austrian Institute of Technology GmbH
Neurology
311d
Cleared
Mar 14, 2018
Natus NeuroWorks
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology
26d
About Product Code OMB - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code OMB since 1987, with 42 receiving FDA clearance (average review time: 157 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OMB Product Code
FDA review times for OMB submissions have been consistent, averaging 173 days recently vs 153 days historically.
OMB devices are reviewed by the Neurology panel. Browse all Neurology devices →