GWN · Class II · 21 CFR 882.1460

FDA Product Code GWN: Nystagmograph

Leading manufacturers include Kelleher Corp., Bio-Logic Systems Corp. and Neuro Kinetics, Inc..

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 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 Feb 03, 1995
VARIOUS ELECTRODES
K941928
Bio-Logic Systems Corp.
Neurology · 289d
Cleared Jun 10, 1992
JANUS ATAC ENG ANALYSIS SYSTEM
K904385
Life-Tech Intl., Inc.
Neurology · 625d
Cleared Apr 30, 1986
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457
Oxford Medilog, Inc.
Neurology · 84d
Cleared Nov 27, 1985
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190
Nicolet Biomedical Instruments
Neurology · 246d
Cleared Jul 22, 1985
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180
Bio-Logic Systems Corp.
Neurology · 186d
Cleared Dec 12, 1984
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
K842886
Teca, Inc.
Neurology · 142d
Cleared Jan 28, 1983
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268
Kelleher Corp.
Neurology · 183d
Cleared Aug 16, 1982
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266
Kelleher Corp.
Neurology · 18d

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 →