GYB · Class II · 21 CFR 882.1275

FDA Product Code GYB: Media, Electroconductive

Leading manufacturers include Vanaray Laboratories, Inc., Chester Labs, Inc. and Graphic Controls Corp..

69
Total
69
Cleared
151d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 124d recently vs 151d historically

FDA 510(k) Cleared Media, Electroconductive Devices (Product Code GYB)

69 devices
1–24 of 69
Cleared Apr 08, 2025
Jmoon Conductive Gel
K243749
Shenzhen Ulike Smart Electronics Co., Ltd.
Neurology · 124d
Cleared Sep 15, 2023
Avologi Gel Primer (Model: Av25)
K220735
Premier North America, Inc.
Neurology · 550d
Cleared Dec 13, 2022
Conductive Gel
K222770
Top-Rank Health Care Co., Ltd.
Neurology · 90d
Cleared Sep 23, 2022
Conductive Gel
K221724
Tone-A-Matic International, Inc.
Neurology · 101d
Cleared Jun 15, 2022
EEG-acp
K212325
Somnomedics GmbH
Neurology · 324d
Cleared Dec 01, 2021
AC Cream - Conductive paste
K212326
Spes Medica Srl
Neurology · 128d
Cleared Nov 08, 2021
GT5 conductive & abrasive gel
K212787
Wuhan Greentek Pty , Ltd.
Neurology · 68d
Cleared Nov 25, 2020
DR-HO'S Electro Therapy Conductive Gel
K200402
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 280d
Cleared Feb 07, 2020
Elefix V Paste for EEG & EMG
K191975
Nihon Kohden Corporation
Neurology · 198d
Cleared Jan 17, 2020
SAC2 - Electrode Cream
K192606
Spes Medica Srl
Neurology · 119d
Cleared Jul 19, 2019
Tech Dots - Adhesive and conductive gel
K190050
Spes Medica Srl
Neurology · 190d
Cleared Feb 07, 2017
EndyGel
K161715
Endymed Medical, Ltd.
Neurology · 231d
Cleared Dec 30, 2016
NuFACE Gel Primer
K161654
Carol Cole Company
Neurology · 198d
Cleared Jan 05, 2012
ELECTRO-GEL
K111717
Electro-Cap Intl., Inc.
Neurology · 199d
Cleared Jul 30, 2004
THERA-CREAM, MODEL TCT004
K032239
Prizm Medical, Inc.
Neurology · 375d
Cleared Dec 17, 2003
CONDUCTIVE EEG ELECTROLYTE
K033052
Compumedics USA, Ltd.
Neurology · 79d
Cleared Jun 13, 2003
LEKTROGEL, MODEL LK3001
K030887
Inmed Ltda.
Neurology · 84d
Cleared Dec 02, 2002
HOME CARE JELLY
K022494
Roc Chinese-European Industrial Research Society
Neurology · 126d
Cleared Sep 13, 2002
CONDUCTIVE GEL
K022006
The Dezac Group
Neurology · 86d
Cleared Aug 24, 2001
MAVIDON MEDICAL ELECTRODE JELLY
K003924
Mavidon Medical Products
Neurology · 247d
Cleared Aug 06, 2001
CONDUCTIVE GEL FOR ULTRASOUND
K002832
Skylark Device & Systems Co., Ltd.
Neurology · 329d
Cleared Jun 29, 2000
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
K001705
Chester Labs, Inc.
Neurology · 24d
Cleared Dec 09, 1998
BATCH #6060 CONDUCTIVE GEL
K983964
Skylark Device Co., Ltd.
Neurology · 33d
Cleared May 14, 1997
MODEL 1700, HYDRO PREP
K970694
Physiometrix, Inc.
Neurology · 78d

About Product Code GYB - Regulatory Context

510(k) Submission Activity

69 total 510(k) submissions under product code GYB since 1977, with 69 receiving FDA clearance (average review time: 151 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - GYB Product Code

Recent submissions under GYB have taken an average of 124 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.

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