Product Code: EZL FDA class 2 21 CFR 876.5130

Catheter, Retention Type, Balloon

Gastroenterology, Urology

The Balloon Retention-Type Catheter (product code EZL) is an indwelling urinary catheter fitted with an inflatable balloon near its tip that is inflated after insertion to keep the catheter in position within the bladder. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket notification. It is regulated under 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

128

FEI Numbers

119

Registration Numbers

119

Unique Applicants

Years Active

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Basic Information

Product Code: EZL
Device Class: FDA class 2
Regulation Number: 876.5130
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 128 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252537	Rusch SoftSimplastic Foley Catheters	Jan 20, 2026	Substantially Equivalent	Teleflex Medical Sdn. Bhd.
K243011	Silicone Urethral Catheter (Silicone Urethral Catheter)	Jun 16, 2025	Substantially Equivalent	Guangdong Ecan Medical Co., Ltd.
K241424	InnoCare Specialty Foley Catheter	Sep 18, 2024	Substantially Equivalent	Innocare Urologics, LLC
K232469	Rüsch Latex Gold Foley Catheter	Aug 01, 2024	Substantially Equivalent	Teleflexmedical, Inc.
K240057	TraumaGuard Intra-abdominal Pressure Sensing System	Apr 17, 2024	Substantially Equivalent	Sentinel Medical Technologies, LLC
K233411	Folysil Silicone Catheter	Apr 15, 2024	Substantially Equivalent	Coloplast Corp.
K233013	2-Way 100% Silicone Cleartract Catheter	Jan 23, 2024	Substantially Equivalent	Silq Technologies Corporation
K212077	Teleflex Rusch SoftSimplastic Foley Catheters	Jul 27, 2023	Substantially Equivalent	Teleflexmedical, Inc.
K231101	Flume Catheter	Jun 29, 2023	Substantially Equivalent	Flume Catheter Company, Ltd.
K221020	Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F	Jan 13, 2023	Unknown	Potrero Medical, Inc.
K222118	2-Way 100% Silicone Cleartract Catheter	Dec 01, 2022	Substantially Equivalent	Silq Technologies, Corp.
K221625	2-Way 100% Silicone ClearTract Catheter	Jul 01, 2022	Substantially Equivalent	Silq Technologies Corporation
K212151	FLUME catheter	Nov 03, 2021	Substantially Equivalent	The Flume Catheter Company, Ltd.
K202134	Well Lead All Silicone Foley Catheter with Temperature Sensor	Apr 08, 2021	Substantially Equivalent	Well Lead Medical Co., Ltd.
K201776	Foley Balloon Catheter for Urology	Dec 30, 2020	Substantially Equivalent	Apollon Co., Ltd.
K202698	Prefilled Syringe	Dec 15, 2020	Substantially Equivalent	Hangzhou Primecare Medical Co., Ltd.
K192034	HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc	Apr 21, 2020	Substantially Equivalent	Pathway, LLC
K200556	AquaFlate Pre-Filled Sterile Water Syringe 10mL	Mar 31, 2020	Substantially Equivalent	H R Pharmaceuticals, Inc.
K182463	Silicone Foley Catheter	Nov 06, 2019	Substantially Equivalent	Biosensors International Pte, Ltd.
K190060	Urethrotech UCD	Oct 04, 2019	Substantially Equivalent	Urethrotech
K182635	Signal Catheter	Jan 10, 2019	Substantially Equivalent	Safe Medical Design
K181616	PSM 3-Way Silicone Foley Catheter	Sep 21, 2018	Substantially Equivalent	Pathway, LLC
K180781	Bard Vertus Foley Catheter	Sep 19, 2018	Substantially Equivalent	C.R. Bard, Inc.
K181814	AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water	Sep 04, 2018	Substantially Equivalent	Amsino International, Inc.
K173657	Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter	Aug 23, 2018	Substantially Equivalent	Cook Incorporated
K181346	CystoSure Plus Catheter	Aug 06, 2018	Substantially Equivalent	Emmy Medical, LLC
K173340	Yikang Latex Foley Catheter	Jul 13, 2018	Substantially Equivalent	Jiangxi Yikang Medical Instrument Group Co., Ltd.
K172807	Silicone Foley Catheter for single use	Jun 04, 2018	Substantially Equivalent	Changzhou Rongxin Medicine Minimal Invasion Technology
K173533	Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter	Mar 29, 2018	Substantially Equivalent	Poiesis Medical, LLC
K172422	Kohli Urinary Drainage Catheter	Feb 09, 2018	Substantially Equivalent	Nellie Medical, LLC
K161770	Rusch Silicone Foley Catheter	May 05, 2017	Substantially Equivalent	Teleflexmedical, Inc.
K162989	Rusch Simplastic Foley Catheters	Feb 24, 2017	Substantially Equivalent	Teleflexmedical, Inc.
K153655	Accuryn Monitoring System	Apr 15, 2016	Unknown	Potrero Medical, Inc.
K150550	SilverCoat Silicone Foley Catheter	Nov 24, 2015	Substantially Equivalent	Covalontechnologies, Inc.
K150699	Bard LubriGuard Foley Catheter	Jul 28, 2015	Substantially Equivalent	C.R. Bard, Inc.
K142635	Medline Silicone Foley Catheter	Jan 09, 2015	Substantially Equivalent	Medline Industries, Inc.
K140667	WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER	Dec 15, 2014	Substantially Equivalent	Well Lead Medical Co., Ltd.
K140099	LIGHTHOUSE URINARY CATHETER	Mar 04, 2014	Substantially Equivalent	Seedings Life Science Ventures, LLC
K131655	LIGHTHOUSE(TM) URINARY CATHETER	Nov 04, 2013	Substantially Equivalent	Seedings Life Science Ventures, LLC
K130908	DISPOSABLE SILICONE FOLEY CATHETER	Oct 03, 2013	Substantially Equivalent	Guangdong Baihe Medical Technology Co., Ltd.
K131020	TEMPERATURE SENSOR CATHETER	May 09, 2013	Substantially Equivalent	Degania Silicone , Ltd.
K110214	DIRECTVISION CATHETER, UNCOATED	May 27, 2011	Substantially Equivalent	Percuvision
K103371	COUDE/ OR TIEMANN	Mar 11, 2011	Substantially Equivalent	Degania Silicone , Ltd.
K101824	AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER	Sep 13, 2010	Substantially Equivalent	Amsino International, Inc.
K091516	WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR	Oct 16, 2009	Substantially Equivalent	Well Lead Medical Co., Ltd.
K091767	3 WAY SILICONE FOLEY BALLOON CATHETER	Oct 09, 2009	Substantially Equivalent	Cook Urological, Inc.
K091699	AMSURE HYDROPHILIC LATEX FOLEY CATHETER	Aug 10, 2009	Substantially Equivalent	Amsino International, Inc.
K090262	PERCUCATH URINARY CATHETER	May 28, 2009	Substantially Equivalent	Percuvision, LLC
K082919	UC-CARE POSITIONING SYSTEM	Oct 27, 2008	Substantially Equivalent	Uc-Care Medical Systems, Ltd.
K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	Oct 08, 2008	Substantially Equivalent	Well Lead Medical Instruments
K070582	BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS	Dec 07, 2007	Substantially Equivalent	C.R. Bard, Inc.
K070558	BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS	Dec 07, 2007	Substantially Equivalent	C.R. Bard, Inc.
K071049	DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR	Oct 16, 2007	Substantially Equivalent	Tyco Healthcare
K071423	MEDLINE LATEX FOLEY CATHETER	Jul 18, 2007	Substantially Equivalent	Medline Industries, Inc.
K062112	SUNMED FOLEY CATHETERS	Jun 04, 2007	Substantially Equivalent	Sunmed, Inc.
K063442	ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR	Mar 26, 2007	Substantially Equivalent	Degania Silicone , Ltd.
K070508	BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR	Mar 09, 2007	Substantially Equivalent	C.R. Bard, Inc.
K052168	MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.	Feb 16, 2006	Substantially Equivalent	Medline Industries, Inc.
K053429	ADVANCED UROLOGICAL CATHETER	Feb 08, 2006	Substantially Equivalent	Entracare, LLC
K051059	AMSURE 100% SILICONE FOLEY CATHETER	Jun 28, 2005	Substantially Equivalent	Amsino International, Inc.
K042110	BEAMCATH	Feb 25, 2005	Substantially Equivalent	Beampoint AB
K042709	DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER	Jan 18, 2005	Substantially Equivalent	Tyco Healthcare
K041983	OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016	Nov 17, 2004	Substantially Equivalent	Opticon Medical
K040504	BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS	May 14, 2004	Substantially Equivalent	C.R. Bard, Inc.
K033830	OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000	Jan 09, 2004	Substantially Equivalent	Opticon Medical, Inc.
K030120	AMSURE FOLEY CATHETER	Oct 29, 2003	Substantially Equivalent	Amsino International, Inc.
K031748	VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES	Aug 27, 2003	Substantially Equivalent	Vitalcare Group, Inc.
K024010	DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER	Jun 11, 2003	Substantially Equivalent	The Kendall Company Div. of Tyco Healthcare Group
K030813	PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND	May 30, 2003	Substantially Equivalent	Primary Care Solutions, Inc.
K021939	VITALCARE FOLEY CATHETER	Apr 22, 2003	Substantially Equivalent	Vitalcare, Inc.
K023090	OPTION-VF URINARY CATHETER, FV14218	Mar 19, 2003	Substantially Equivalent	Opticon Medical, Inc.
K021142	ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865	Oct 01, 2002	Substantially Equivalent	Fortune Medical Instrument Corp.
K022287	3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS	Sep 23, 2002	Substantially Equivalent	3t Medical Systems, LLC
K002612	BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON	Sep 03, 2002	Substantially Equivalent	C.R. Bard, Inc.
K013276	ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)	Feb 15, 2002	Substantially Equivalent	Sewoon Medical Co., Ltd.
K013174	PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,	Jan 04, 2002	Substantially Equivalent	Porges S.A.
K013172	PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL	Dec 20, 2001	Substantially Equivalent	Porges S.A.
K010006	DRAINAGE CATHETER OR FOLEY CATHETER	Jul 25, 2001	Substantially Equivalent	Applied Medical Resources Corp.
K003784	MENTOR SELF-CATH PLUS	Mar 05, 2001	Substantially Equivalent	Mentor Corp.
K003289	BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU	Jan 05, 2001	Substantially Equivalent	C.R. Bard, Inc.
K002868	BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER	Dec 08, 2000	Substantially Equivalent	C.R. Bard, Inc.
K993063	RUSCH BRILLANT SILICONE FOLEY	Dec 09, 1999	Substantially Equivalent	Rusch Intl.
K990500	KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C	Sep 28, 1999	Substantially Equivalent	The Kendal Co.
K990509	OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818	May 18, 1999	Substantially Equivalent	Implemed, Inc.
K984084	BARDEX LUBRI-SIL FOLEY CATHETER	Feb 01, 1999	Substantially Equivalent	Bard Medical Div.
K982970	MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER	Oct 28, 1998	Substantially Equivalent	Mri Manufacturing and Research, Inc.
K973076	EUROMEDICAL HAEMATURIA FOLEY CATHETER	Sep 16, 1998	Substantially Equivalent	Unomedical Sdn Bhd
K982626	URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0	Aug 20, 1998	Substantially Equivalent	Medworks Corp.
K981612	ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER	Jul 08, 1998	Substantially Equivalent	Rochester Medical Corp.
K980870	RUSCH SILICONE FOLEY CATHETER	Jun 09, 1998	Substantially Equivalent	Rusch, Inc.
K980919	ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER	Mar 31, 1998	Substantially Equivalent	Fortune Medical Instrument Corp.
K974419	RUSCH SIMPLASTIC COUNCILL TIP CATHETER	Jan 27, 1998	Substantially Equivalent	Rusch, Inc.
K972184	RUSCH BRILLANT SILICONE FOLEY CATHETER	Jan 08, 1998	Substantially Equivalent	Rusch Intl.
K971643	RUSCH BRILLANT BALLOON CATHETER	Oct 07, 1997	Substantially Equivalent	Rusch Intl.
K971796	LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS	Aug 12, 1997	Substantially Equivalent	Louisville Laboratories, Inc.
K971801	LAPAROTOMY BLADDER NECK SUSPENSION KIT	Jul 22, 1997	Substantially Equivalent	Louisville Laboratories, Inc.
K964757	CONTIDRAIN CATHETER	Jun 25, 1997	Substantially Equivalent	Contimed, Inc.
K970716	OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE	May 16, 1997	Substantially Equivalent	Opticon Medical, Inc.
K964575	SYMPACATH HYDROGEL COATED FOLEY	Feb 04, 1997	Substantially Equivalent	Rusch Intl.
K961697	OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE	Aug 30, 1996	Substantially Equivalent	Medical Device Intl., Inc.
K944673	MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE	Apr 10, 1996	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944676	MRI'S ALL SILICONE FOLEY CATHETER	Apr 05, 1996	Substantially Equivalent	Mri Manufacturing and Research, Inc.
K954752	PEDIATRIC EUROPHYLIC FOLEY CATHETER	Oct 30, 1995	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944007	EUROPHILIC SLIPPERY COATED FOLEY CATHETER	Jun 29, 1995	Substantially Equivalent	Baxter Healthcare Corp
K951106	SILICONE FOLEY CATHETER	May 25, 1995	Substantially Equivalent	Cook Urological, Inc.
K951103	SILASTIC BRAND FOLEY CATHETER	Apr 28, 1995	Substantially Equivalent	C.R. Bard, Inc.
K945806	SILICATH ALL SILICONE FOLEY CATHETER	Mar 21, 1995	Substantially Equivalent	Unomedical Sdn Bhd
K941692	FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER	Mar 06, 1995	Substantially Equivalent	Rochester Medical Corp.
K944382	ORION ALL SILICONE FOLEY CATHETER	Dec 06, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944381	ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE	Nov 30, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944380	ORION FOLEY CATHETER	Nov 30, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K944376	ORION ALL SILICONE ELASTOMER COATED CATHETER	Nov 30, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K941488	DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER	Nov 30, 1994	Substantially Equivalent	Medical Technology Development Corp.
K934895	GLASSMAN SILICONE CATHETER	Oct 13, 1994	Substantially Equivalent	Axiom Medical, Inc.
K935630	NORTA	Oct 07, 1994	Substantially Equivalent	Beiersdorf, Inc.
K930344	SILICONE FOLEY CATHETER	Apr 15, 1994	Substantially Equivalent	Cook Urological, Inc.
K932809	FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR	Mar 17, 1994	Substantially Equivalent	Excalibur Engineering Care of Rms, Inc.
K911617	UROTECH CATHETER	Feb 25, 1993	Substantially Equivalent	Urotech U.S.A., Inc.
K922821	YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES	Nov 23, 1992	Substantially Equivalent	Yellow Springs Instrument Co., Inc.
K921561	YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES	Nov 23, 1992	Substantially Equivalent	Ysis, Inc.
K905042	COMFORT SLEEVED ALL SILICONE FOLEY CATHETER	Jan 18, 1991	Substantially Equivalent	Rochester Medical Corp.
K903777	WRP FOLEYCATH	Dec 13, 1990	Substantially Equivalent	Wembley Rubber Products (M) Sdn Bhd
K902710	FOLEY CATHETER	Nov 21, 1990	Substantially Equivalent	Societa Gruppi Elastomeri S.A.
K894883	PHYCON ALL SILICONE BALLOON CATHETER	Apr 25, 1990	Substantially Equivalent	Vitaid, Ltd.
K810691	CURITY 100% SILICONE IRRIGATION FOLEY	Mar 13, 1981	Unknown	The Kendal Co.
K780062	CATHETER/HEMOSTATIC/GERIATRIC	Feb 14, 1978	Substantially Equivalent	Kendall Research Center
K772218	CATHETER, SILICONE COATED	Dec 13, 1977	Substantially Equivalent	Concord Laboratories, Inc.
K771860	FOLHY CATHETER	Oct 18, 1977	Substantially Equivalent	Polysil, Inc.