GWL · Class II · 21 CFR 882.1835

FDA Product Code GWL: Amplifier, Physiological Signal

Leading manufacturers include Nihon Kohden America, Inc., Eb Neuro S.P.A. and Honeywell, Inc..

53
Total
53
Cleared
114d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 98d avg (recent)

FDA 510(k) Cleared Amplifier, Physiological Signal Devices (Product Code GWL)

53 devices
1–24 of 53
Cleared Mar 12, 2025
Delphi Amplifier
K243746
Quantalx Neroscience
Neurology · 97d
Cleared Dec 12, 2024
NExT Station
K242832
Eb Neuro S.P.A.
Neurology · 84d
Cleared Sep 04, 2024
DreamClear
K240646
Somnomed Technologies Inc., Doing Business AS Remware
Neurology · 181d
Cleared Sep 04, 2024
BE Plus PRO, Neurotravel LIGHT
K242305
Eb Neuro S.P.A.
Neurology · 30d
Cleared Feb 04, 2024
X-trodes System M
K232210
X-Trodes
Neurology · 193d
Cleared Oct 11, 2023
Vlab
K230148
Dormotech Medical, Ltd.
Neurology · 265d
Cleared Jun 01, 2023
SomniCheck
K223676
Brainmatterz, LLC
Neurology · 175d
Cleared Jul 15, 2022
NomadAir PMU810
K220631
Neurotronics, Inc.
Neurology · 133d
Cleared May 20, 2021
Quick-20m
K203331
Cgx, LLC
Neurology · 189d
Cleared Feb 10, 2021
Digital NeuroPort Biopotential Signal Processing System
K202174
Blackrock Microsystems
Neurology · 190d
Cleared Dec 27, 2020
8-CH Electroencephalography Amplifier
K201747
Hipposcreen Neurotech Corp.
Neurology · 184d
Cleared Mar 30, 2018
eego amplifiers
K172312
Eemagine Medical Imaging Solutions GmbH
Neurology · 241d
Cleared Sep 14, 2005
SINGLE AMPLIFIER FOR BOTOX
K051852
Allergan, Inc.
Neurology · 68d
Cleared Sep 30, 1988
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177
Nihon Kohden America, Inc.
Neurology · 196d
Cleared Sep 30, 1987
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794
Nihon Kohden America, Inc.
Neurology · 216d
Cleared Jul 16, 1987
NICOLET AMP 6R11 SYSTEM
K871678
Nicolet Biomedical Instruments
Neurology · 79d
Cleared Jun 07, 1984
NEUROPACK II 5100
K841612
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Nov 21, 1977
AMPLIFIER OTRONA, MODEL N3A-EMG
K772102
Honeywell, Inc.
Neurology · 14d
Cleared Sep 20, 1977
AMPLIFIER MODEL N3B-EEG
K771683
Honeywell, Inc.
Neurology · 14d

About Product Code GWL - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code GWL since 1977, with 53 receiving FDA clearance (average review time: 114 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GWL Product Code

FDA review times for GWL submissions have been consistent, averaging 98 days recently vs 115 days historically.

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