GWJ · Class II · 21 CFR 882.1900

FDA Product Code GWJ: Stimulator, Auditory, Evoked Response

Leading manufacturers include Bio-Logic Systems Corp., Teca, Inc. 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 Feb 05, 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626
Bio-Logic Systems Corp.
Neurology · 41d
Cleared May 09, 2003
STACKED ABR FOR NAVIGATOR PRO
K030907
Bio-Logic Systems Corp.
Neurology · 46d
Cleared Apr 28, 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009
Bio-Logic Systems Corp.
Neurology · 28d
Cleared Jul 01, 2002
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895
Bio-Logic Systems Corp.
Neurology · 21d
Cleared May 15, 2002
BIO-LOGIC ABAER CUB
K021215
Bio-Logic Systems Corp.
Neurology · 28d
Cleared Dec 27, 1999
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149
Bio-Logic Systems Corp.
Neurology · 19d
Cleared Sep 14, 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807
Bio-Logic Systems Corp.
Neurology · 25d
Cleared Jan 30, 1998
EXCEL AV STIM 1000
K972157
Excel Tech. , Ltd.
Neurology · 235d
Cleared Jan 30, 1992
DANTEC COUNTERPOINT MK2(TM)
K913957
Dantec Medical, Inc.
Neurology · 148d
Cleared Feb 04, 1987
TECA/MEDELEC AS-10 SENSOR
K862906
Teca, Inc.
Neurology · 188d
Cleared Feb 03, 1987
TECA/MEDELEC AUDIOSTAR
K863156
Teca, Inc.
Neurology · 169d
Cleared Jan 29, 1987
EVOPORT 100
K863985
Jedmed Instrument Co.
Neurology · 107d
Cleared Sep 17, 1986
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Sep 17, 1986
INSERT EARPHONES
K862363
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Mar 08, 1983
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K830579
Nicolet Biomedical Instruments
Neurology · 13d
Cleared Aug 25, 1982
AUDIOMETERS (VARIOUS MODELS)
K822177
Kelleher Corp.
Neurology · 33d
Cleared Dec 14, 1981
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K813009
Teca, Inc.
Neurology · 48d

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 →