GWQ · Class II · 21 CFR 882.1400

FDA Product Code GWQ: Full-montage Standard Electroencephalograph

Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations

Leading manufacturers include Cadwell Industries, Inc., Zeto, Inc. and Bioserenity Sas.

188
Total
188
Cleared
145d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 8 in the prior period
Review times improving: avg 30d recently vs 145d historically

FDA 510(k) Cleared Full-montage Standard Electroencephalograph Devices (Product Code GWQ)

188 devices
1–24 of 188
Cleared Mar 13, 2026
New Wave System
K260455
Zeto, Inc.
Neurology · 30d
Cleared Apr 30, 2024
Flexset System
K233403
Zeto, Inc.
Neurology · 209d
Cleared Nov 09, 2023
Neuronaute Plus
K231366
Bioserenity Sas
Neurology · 182d
Cleared Aug 31, 2023
Q21
K221959
Neurofield, Inc.
Neurology · 422d
Cleared Aug 18, 2023
SPARK Scan
K231457
Spark Neuro, Inc.
Neurology · 91d
Cleared Apr 27, 2023
Cumulus Functional Neurophysiology Platform
K221963
Cumulus Neuroscience Limited
Neurology · 296d
Cleared Feb 09, 2023
Okti
K230073
Compumedics Limited
Neurology · 30d
Cleared Jan 12, 2023
Neuronaute with IceCap 2 & IceCap 2 Small
K223644
Bioserenity
Neurology · 37d
Cleared Aug 10, 2022
iSyncWave
K220056
iMediSync, Inc.
Neurology · 216d
Cleared Jun 16, 2022
Seer Home
K212788
Seer Medical Pty, Ltd.
Neurology · 288d
Cleared May 06, 2022
WAVi SCAN EEG System and Accessories
K213900
Wavi Co.
Neurology · 143d
Cleared Dec 30, 2020
NeuroAmp II, NeuroAmp II.5s
K193159
Corscience GmbH & Co. KG
Neurology · 411d
Cleared Dec 10, 2020
Neuronaute
K202334
Bioserenity Sas
Neurology · 115d
Cleared Sep 29, 2020
Cadwell Apollo System
K201819
Cadwell Industries, Inc.
Neurology · 90d
Cleared Apr 24, 2020
Maxxi Position Sensor
K191492
Neurovirtual USA, Inc.
Neurology · 324d
Cleared Mar 31, 2020
iCEWav Neuromonitoring Platform
K191868
Ice Neurosystems, Inc.
Neurology · 263d
Cleared Mar 17, 2020
NeuralScan System
K192753
Medeia, Inc.
Neurology · 169d
Cleared Sep 01, 2018
Cadwell Zenith System
K181466
Cadwell Industries, Inc.
Neurology · 89d
Cleared Jul 17, 2018
Cadwell Apollo System
K180269
Cadwell Industries, Inc.
Neurology · 167d
Cleared Jun 14, 2018
Natus Brain Monitor Amplifier
K180290
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 133d
Cleared May 04, 2018
Trackit T4 EEG Amplifier
K172271
Lifelines , Ltd.
Neurology · 280d
Cleared Apr 17, 2018
WR19 System
K172735
Zeto, Inc.
Neurology · 218d
Cleared Feb 22, 2018
Natus Quantum
K180181
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Neurology · 30d
Cleared Feb 16, 2018
NeuroEEG
K173460
Memory MD, Inc.
Neurology · 101d

About Product Code GWQ - Regulatory Context

510(k) Submission Activity

188 total 510(k) submissions under product code GWQ since 1977, with 188 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 8 in the prior period.

FDA 510(k) Review Time - GWQ Product Code

Recent submissions under GWQ have taken an average of 30 days to reach a decision - down from 145 days historically, suggesting improved FDA processing for this classification.

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