GWN · Class II · 21 CFR 882.1460

FDA Product Code GWN: Nystagmograph

Leading manufacturers include Interacoustics A/S, Neuro Kinetics, Inc. and Bio-Logic Systems Corp..

60
Total
60
Cleared
151d
Avg days
1981
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 186d recently vs 149d historically

FDA 510(k) Cleared Nystagmograph Devices (Product Code GWN)

60 devices
1–24 of 60
Cleared Jul 30, 2026
SMARTVERTIGO™ Vestibular Assessment System
K260566
VertigoDx, Inc.
Ear, Nose, Throat · 161d
Cleared Aug 25, 2025
NeuroEars-Anna™
K243709
Neuroears, Inc.
Ear, Nose, Throat · 266d
Cleared Feb 14, 2025
ICS Dizcovery (1091)
K242198
Natus Medical Denmark Aps
Ear, Nose, Throat · 203d
Cleared Jan 03, 2025
Synapsys VHIT
K242726
Inventis S.R.L.
Ear, Nose, Throat · 115d
Cleared Jun 29, 2023
NeuroSwift Pro
K223047
Neurobit Technologies Co., Ltd.
Ear, Nose, Throat · 273d
Cleared Nov 12, 2020
Insight Infrared Video Goggles
K203082
Vestibular First
Ear, Nose, Throat · 30d
Cleared Aug 12, 2020
VisualEyes
K200534
Interacoustics A/S
Ear, Nose, Throat · 163d
Cleared Nov 29, 2019
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
K192186
Neurolign USA, LLC
Ear, Nose, Throat · 109d
Cleared Sep 28, 2018
RightEye Vision System
K181771
Righteye, LLC
Ophthalmic · 87d
Cleared Sep 14, 2018
DizzyDoctor System 1.0.0
K182214
Dizzydoctor Systems, LLC
Ear, Nose, Throat · 30d
Cleared Jul 24, 2018
I-Portal Neuro Otologic Test Center
K181025
Neuro Kinetics, Inc.
Neurology · 97d
Cleared Nov 22, 2017
I-Portal Portable Assessment System - Nystagmograph (I-PAS)
K171884
Neuro Kinetics, Inc.
Ear, Nose, Throat · 152d
Cleared Sep 25, 2017
ISEN-Goggles with Data Viewer
K163270
Isent Tech & Trading Company, Ltd.
Neurology · 308d
Cleared Apr 26, 2017
VisualEyes
K163149
Interacoustics A/S
Neurology · 168d
Cleared Mar 23, 2017
Synapsys Ulmer Video Nystagmograph
K163558
Synapsys SA
Neurology · 94d
Cleared Apr 26, 2016
ISEN-Goggles
K152727
Isen Tech & Trading Company, Ltd.
Neurology · 217d
Cleared Jan 29, 2016
EYE-SYNC
K152915
Syncthink, Inc.
Neurology · 119d
Cleared Dec 29, 2015
VisualEyes
K152112
Interacoustics A/S
Neurology · 153d
Cleared Nov 16, 2015
ICS Impulse
K151504
Gn Otometrics
Neurology · 165d
Cleared Jul 08, 2015
I-Portal NOTC, VNG and VOG
K143607
Neuro Kinetics, Inc.
Ear, Nose, Throat · 201d
Cleared Sep 06, 2013
EYESEECAM VHIT
K131681
Interacoustics A/S
Neurology · 88d
Cleared Apr 26, 2013
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
K130201
Ototronix, LLC
Neurology · 88d
Cleared Feb 01, 2013
ICS IMPULSE
K122550
Gn Otometrics
Neurology · 164d
Cleared Aug 06, 2009
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
K083603
Neuro Kinetics
Ear, Nose, Throat · 244d

About Product Code GWN - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code GWN since 1981, with 60 receiving FDA clearance (average review time: 151 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GWN Product Code

Recent submissions under GWN have taken an average of 186 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.

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