GYB · Class II · 21 CFR 882.1275

FDA Product Code GYB: Media, Electroconductive

Leading manufacturers include Graphic Controls Corp., Parker Laboratories, Inc. and Cadwell Laboratories, Inc..

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 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
Cleared Mar 19, 1997
HYDROPREP GEL
K964737
D.O. Weaver Co.
Neurology · 114d
Cleared Oct 04, 1996
ECOGEL 300 TENS GEL
K962681
Eco-Med Pharmaceuticals, Inc.
Neurology · 86d
Cleared Jul 09, 1996
MEDI-TRACE DEFIB PADS
K955597
Graphic Controls Corp.
Neurology · 214d
Cleared May 07, 1996
GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
K944598
Chester Labs, Inc.
Neurology · 596d
Cleared May 07, 1996
GRAHAM-FIELD CONDUCTIVE ECG SPRAY
K944599
Chester Labs, Inc.
Neurology · 596d
Cleared May 27, 1994
TEN-20 CONDUCTIVE PASTE GEL
K933799
Cadwell Laboratories, Inc.
Neurology · 296d
Cleared May 17, 1994
OMNI PREP GEL
K933797
Cadwell Laboratories, Inc.
Neurology · 286d
Cleared Mar 22, 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804
Cadwell Laboratories, Inc.
Neurology · 230d

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 →