Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GYB — Predicate Candidate Screening

69 FDA 510(k) clearances under this product code; the 50 most recent screened below.

100 daysmedian FDA review time

329 days90th percentile

69clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243749	Jmoon Conductive Gel	Shenzhen Ulike Smart Electronics Co., Ltd.	2025-04-08	124	0
K220735	Avologi Gel Primer (Model: Av25)	Premier North America, Inc.	2023-09-15	550	0
K222770	Conductive Gel	Top-Rank Health Care Co., Ltd.	2022-12-13	90	0
K221724	Conductive Gel	Tone-A-Matic International, Inc.	2022-09-23	101	0
K212325	EEG-acp	Somnomedics GmbH	2022-06-15	324	0
K212326	AC Cream - Conductive paste	Spes Medica Srl	2021-12-01	128	0
K212787	GT5 conductive & abrasive gel	Wuhan Greentek Pty , Ltd.	2021-11-08	68	0
K200402	DR-HO'S Electro Therapy Conductive Gel	Guangzhou Xinbo Electronic Co., Ltd.	2020-11-25	280	0
K191975	Elefix V Paste for EEG & EMG	Nihon Kohden Corporation	2020-02-07	198	0
K192606	SAC2 - Electrode Cream	Spes Medica Srl	2020-01-17	119	0
K190050	Tech Dots - Adhesive and conductive gel	Spes Medica Srl	2019-07-19	190	0
K161715	EndyGel	Endymed Medical, Ltd.	2017-02-07	231	0
K161654	NuFACE Gel Primer	Carol Cole Company	2016-12-30	198	0
K111717	ELECTRO-GEL	Electro-Cap Intl., Inc.	2012-01-05	199	0
K032239	THERA-CREAM, MODEL TCT004	Prizm Medical, Inc.	2004-07-30	375	0
K033052	CONDUCTIVE EEG ELECTROLYTE	Compumedics USA, Ltd.	2003-12-17	79	0
K030887	LEKTROGEL, MODEL LK3001	Inmed Ltda.	2003-06-13	84	0
K022494	HOME CARE JELLY	Roc Chinese-European Industrial Research Society	2002-12-02	126	0
K022006	CONDUCTIVE GEL	The Dezac Group	2002-09-13	86	0
K003924	MAVIDON MEDICAL ELECTRODE JELLY	Mavidon Medical Products	2001-08-24	247	0
K002832	CONDUCTIVE GEL FOR ULTRASOUND	Skylark Device & Systems Co., Ltd.	2001-08-06	329	0
K001705	STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE	Chester Labs, Inc.	2000-06-29	24	0
K983964	BATCH #6060 CONDUCTIVE GEL	Skylark Device Co., Ltd.	1998-12-09	33	0
K970694	MODEL 1700, HYDRO PREP	Physiometrix, Inc.	1997-05-14	78	2
K964737	HYDROPREP GEL	D.O. Weaver Co.	1997-03-19	114	0
K962681	ECOGEL 300 TENS GEL	Eco-Med Pharmaceuticals, Inc.	1996-10-04	86	0
K955597	MEDI-TRACE DEFIB PADS	Graphic Controls Corp.	1996-07-09	214	0
K944599	GRAHAM-FIELD CONDUCTIVE ECG SPRAY	Chester Labs, Inc.	1996-05-07	596	0
K944598	GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL	Chester Labs, Inc.	1996-05-07	596	0
K944600	GRAHAM-FIELD SALINE ELECTROLYTE GEL	Chester Labs, Inc.	1995-11-20	427	0
K933799	TEN-20 CONDUCTIVE PASTE GEL	Cadwell Laboratories, Inc.	1994-05-27	296	0
K933797	OMNI PREP GEL	Cadwell Laboratories, Inc.	1994-05-17	286	0
K933804	LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL	Cadwell Laboratories, Inc.	1994-03-22	230	0
K925466	CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON	Uni-Patch, Inc.	1993-08-26	301	0
K904377	ELECTROCONDUCTIVE MEDIA	Henley Intl.	1991-11-15	417	0
K904889	TENS CONDUCTIVE MEDIA PAD	Creative Design Systems, Inc.	1991-05-14	204	0
K901630	CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)	Henley Intl.	1990-07-16	98	0
K893604	TENS PREP	Smith & Nephew United, Inc.	1989-11-21	189	0
K883149	TEN20 CONDUCTIVE	Weaver & Co.	1988-09-28	64	0
K872045	CONDUCTIVITY GEL	Futuremed Div. of Future Impex Corp.	1987-07-15	49	0
K871913	CONDUCTIVITY GEL	Futuremed Div. of Future Impex Corp.	1987-07-15	58	0
K862799	SKIN PURE	Nihon Kohden America, Inc.	1986-11-13	114	0
K860210	ELEFIX ELECTRODE CREAM	Nihon Kohden America, Inc.	1986-07-01	160	0
K852956	CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION	Parker Laboratories, Inc.	1985-08-09	29	3
K841871	LIQUA-SONIC GEL	Chester Labs, Inc.	1985-03-14	311	0
K833172	ECG-GEL ELECTRODE GEL	Whs Products, Inc.	1983-11-21	66	0
K821539	MEDICOTEST ELECTRODE PASTE	Medicotest, Inc.	1982-07-02	39	0
K820991	KENZ-GELECT GEL PAD	Suzuken Co., Ltd.	1982-04-26	18	0
K812263	KENZ-GELECT	Suzuken Co., Ltd.	1981-11-02	81	0
K812284	ZEE ELECTRODE-GEL	Zee Medical Products Co., Inc.	1981-09-08	26	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda