GWJ · Class II · 21 CFR 882.1900

FDA Product Code GWJ: Stimulator, Auditory, Evoked Response

Leading manufacturers include Bio-Logic Systems Corp., Intelligent Hearing Systems and Path Medical GmbH.

76
Total
76
Cleared
114d
Avg days
1977
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 85d recently vs 114d historically

FDA 510(k) Cleared Stimulator, Auditory, Evoked Response Devices (Product Code GWJ)

76 devices
1–24 of 76
Cleared Dec 19, 2024
Integrity V500 (Integrity, Integrity with VEMP)
K242954
Vivosonic, Inc.
Ear, Nose, Throat · 85d
Cleared Mar 08, 2024
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K233649
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Ear, Nose, Throat · 115d
Cleared Aug 03, 2022
QScreen
K220139
Path Medical GmbH
Ear, Nose, Throat · 197d
Cleared Oct 14, 2021
ALGO 7i
K211147
Path Medical GmbH
Ear, Nose, Throat · 178d
Cleared Apr 24, 2020
GSI Audera Pro
K193033
Grason Stadler
Neurology · 176d
Cleared Sep 29, 2017
SmartEP
K163326
Intelligent Hearing Systems
Neurology · 305d
Cleared Mar 23, 2017
Eclipse with VEMP
K162037
Interacoustics A/S
Neurology · 244d
Cleared Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
K143670
Gn Otometrics A/S
Neurology · 303d
Cleared Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
K141446
Natus Medical Incorporated
Neurology · 81d
Cleared Feb 27, 2014
MADSEN ACCUSCREEN TYPE 1077
K132957
Gn Otometrics
Neurology · 160d
Cleared Jun 27, 2013
EARPROBE
K131141
Path Medical GmbH
Neurology · 65d
Cleared Apr 05, 2013
HEARLAB ACA
K123701
Frye Electronics, Inc.
Neurology · 123d
Cleared Sep 27, 2012
TYPE 1077 ACCUSCREEN
K122067
Gn Otometrics
Neurology · 73d
Cleared Jul 25, 2011
CIRCUMAURAL ADHESIVE REPLACEMENT
K111555
R & D Medical Products, Inc.
Neurology · 52d
Cleared May 05, 2011
TITAN
K103760
Interacoustics A/S
Neurology · 133d
Cleared Jul 01, 2010
EARPROBE
K100661
Path Medical GmbH
Neurology · 115d
Cleared Sep 03, 2009
ICS CHARTR EP 200
K092373
Gn Otometrics
Neurology · 29d
Cleared Jul 07, 2009
SMARTSCREENER-PLUS2
K090579
Intelligent Hearing Systems
Neurology · 126d
Cleared Feb 20, 2009
ICS CHARTR EP 200
K083399
Gn Otometrics A/S
Neurology · 95d
Cleared Jan 29, 2009
MAICO MB 11 WITH BERAPHONE PROBE
K082035
Maico-Diagnostics
Neurology · 196d
Cleared Apr 04, 2008
VIVOSONIC NEUROSCREEN
K080060
Vivosonic, Inc.
Neurology · 86d
Cleared Feb 28, 2008
SMART COUPLER, MODEL M015401
K073384
Intelligent Hearing Systems
Neurology · 87d
Cleared Feb 05, 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626
Bio-Logic Systems Corp.
Neurology · 41d
Cleared Jan 25, 2008
ALGO 5 NEWBORN HEARING SCREENER
K073665
Natus Medical, Inc.
Neurology · 30d

About Product Code GWJ - Regulatory Context

510(k) Submission Activity

76 total 510(k) submissions under product code GWJ since 1977, with 76 receiving FDA clearance (average review time: 114 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - GWJ Product Code

Recent submissions under GWJ have taken an average of 85 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.

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