OLT · Class II · 21 CFR 882.1400

FDA Product Code OLT: Non-normalizing Quantitative Electroencephalograph Software

Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.

Leading manufacturers include Brainz Instruments , Ltd., Teca, Inc. and Pascall Systems, Inc..

56
Total
56
Cleared
173d
Avg days
1981
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 170d avg (recent)

FDA 510(k) Cleared Non-normalizing Quantitative Electroencephalograph Software Devices (Product Code OLT)

56 devices
1–24 of 56
Cleared Sep 16, 2026
Ceribell EEG Analysis Software
K261712
Ceribell, Inc.
Neurology · 117d
Cleared Aug 19, 2026
Pascall Sensor Unit (PSU1)
K254213
Pascall Systems, Inc.
Neurology · 233d
Cleared Dec 03, 2025
HippoMind (v1.0)
K251881
Hippoclinic
Neurology · 168d
Cleared Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366
Nihon Kohden Corporation
Neurology · 161d
Cleared Aug 23, 2024
VEEGix EEG System
K240593
Neuroservo, Inc.
Neurology · 175d
Cleared Nov 30, 2022
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254
Neurosoft , Ltd.
Neurology · 303d
Cleared May 11, 2022
Wireless EEG System
K213299
Pascall Systems, Inc.
Neurology · 222d
Cleared Jan 22, 2020
E-EEGX, N-EEGX
K191322
GE Healthcare Finland Oy
Neurology · 252d
Cleared Dec 17, 2019
CNS Envision
K192572
Moberg Research, Inc.
Neurology · 90d
Cleared Nov 23, 2019
Cadwell Bolt Software
K190760
Cadwell Industries, Inc.
Neurology · 243d
Cleared Aug 21, 2015
Lifelines iEEG
K143487
Kvikna Ehf
Neurology · 256d
Cleared Jun 23, 2015
DiscoverEEG System, Model DE-401
K142834
Neurowave Systems, Inc.
Neurology · 266d
Cleared Jun 19, 2015
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K133995
Neurosoft , Ltd.
Neurology · 540d
Cleared Feb 13, 2015
COGNISION EEG/EP SYSTEM
K141316
Neuronetrix Solutions
Neurology · 269d
Cleared Feb 13, 2015
GALILEO NT
K142064
Eb Neuro S.P.A.
Neurology · 198d
Cleared Feb 12, 2014
GEODESICEEG SYSTEM 400 SERIES (GES 400)
K131882
Electrical Geodesics, Inc.
Neurology · 232d
Cleared Mar 25, 2013
LIFELINES IEEG
K123665
Kvikna Ehf
Neurology · 117d
Cleared Nov 06, 2009
VIGILANT EEG MONITOR, VIGILANT 2.0
K091963
Infinite Biomedical Technologies, LLC
Neurology · 128d
Cleared Aug 10, 2009
ZOOM-100DC
K082886
Brainscope Company, Inc.
Neurology · 314d
Cleared Aug 29, 2008
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K080546
Nihon Kohden America, Inc.
Neurology · 183d
Cleared Feb 15, 2008
MODEL I-2000 MONITOR
K072382
Infinite Biomedical Technologies
Neurology · 175d
Cleared Jan 25, 2007
GEODESIC EEG SYSTEM 300
K063797
Electrical Geodesics, Incorporated
Neurology · 34d
Cleared Dec 22, 2006
BWII EEG DIGITAL, MODEL PV 1652
K062533
Neurovirtual USA, Inc.
Neurology · 115d
Cleared Aug 05, 2005
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
K051883
Ge Healthcare
Neurology · 24d

About Product Code OLT - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code OLT since 1981, with 56 receiving FDA clearance (average review time: 173 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OLT Product Code

FDA review times for OLT submissions have been consistent, averaging 170 days recently vs 174 days historically.

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