GWL · Class II · 21 CFR 882.1835

FDA Product Code GWL: Amplifier, Physiological Signal

Leading manufacturers include Eb Neuro S.P.A., G.Tec Medical Engineering GmbH and Nihon Kohden America, Inc..

53
Total
53
Cleared
114d
Avg days
1977
Since
Declining activity - 2 submissions in the last 2 years vs 5 in the prior period
Review times improving: avg 91d recently vs 115d historically

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 Oct 06, 2017
Sienna Ultimate Wireless Amplifier
K171397
Ems Handels Gesellschaft M.B.H.
Neurology · 148d
Cleared Jul 05, 2017
g.Nautilus PRO
K171669
G.Tec Medical Engineering GmbH
Neurology · 30d
Cleared Oct 23, 2015
R-40 EEG Amplifier
K151600
Lifelines , Ltd.
Neurology · 133d
Cleared Feb 26, 2014
NEMUS 2 SYSTEM
K133517
Eb Neuro S.P.A.
Neurology · 103d
Cleared Dec 20, 2012
g.HIamp
K123255
G.Tec Medical Engineering GmbH
Neurology · 63d
Cleared Aug 03, 2012
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K121996
Eb Neuro S.P.A.
Neurology · 25d
Cleared Apr 08, 2011
NICOLET WIRELESS EEG
K103140
Carefusion 209, Inc.
Neurology · 165d
Cleared Mar 18, 2010
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K092699
Neurotronics, Inc.
Neurology · 197d
Cleared May 28, 2009
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
K090957
I2s Micro Implantable Systems, LLC
Neurology · 52d
Cleared May 27, 2009
NEUROMETRIX BIOAMPLIFIER
K083322
Neurometrix, Inc.
Neurology · 196d
Cleared Mar 22, 2007
PORTI 7 PHYSIOLOGICAL AMPLIFIER
K063599
Tms International BV
Neurology · 108d
Cleared May 30, 2006
REFA, PHYSIOLOGICAL AMPLIFIER
K060374
Tms International BV
Neurology · 106d

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 declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - GWL Product Code

Recent submissions under GWL have taken an average of 91 days to reach a decision - down from 115 days historically, suggesting improved FDA processing for this classification.

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