GWN · Class II · 21 CFR 882.1460

FDA Product Code GWN: Nystagmograph

Leading manufacturers include Righteye, LLC, Dizzydoctor Systems, LLC and Neurolign USA, LLC.

59
Total
59
Cleared
151d
Avg days
1981
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 195d recently vs 149d historically

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

59 devices
1–24 of 59
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

About Product Code GWN - Regulatory Context

510(k) Submission Activity

59 total 510(k) submissions under product code GWN since 1981, with 59 receiving FDA clearance (average review time: 151 days).

Submission volume has increased in recent years - 3 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 195 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 Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →