Product Code: FCM FDA class 2 21 CFR 876.5130

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Gastroenterology, Urology

The Sterile Urethral Catheterization Tray With or Without Catheter (product code FCM) is a procedure kit providing all sterile supplies necessary for urethral catheterization, and may include the catheter itself. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FCM
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 60 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254076	BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit	May 29, 2026	Unknown	C.R. Bard, Inc.
K250891	Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C	Jun 06, 2025	Unknown	Convatec Limited
K223821	Self-Cath Closed System	Aug 02, 2023	Substantially Equivalent	Coloplast
K082831	AMSELF CLOSED CATHETERIZATION SYSTEM	Oct 23, 2008	Substantially Equivalent	Amsino International, Inc.
K070939	SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM	Jun 01, 2007	Substantially Equivalent	Coloplast Manufacturing Us, LLC
K070048	GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT	Mar 15, 2007	Substantially Equivalent	Marian Medical, Inc.
K030712	AMSURE URETHRAL CATHETERIZATION TRAY	May 23, 2003	Substantially Equivalent	Amsino International, Inc.
K030664	AMSURE FOLEY INSERTION TRAY	May 23, 2003	Substantially Equivalent	Amsino International, Inc.
K011055	THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS	Jun 06, 2001	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K010420	RUSCH MMG/O'NEIL CATHETER	May 09, 2001	Substantially Equivalent	Rusch, Inc.
K003873	MENTOR SELF-CATH CLOSED SYSTEM	Mar 29, 2001	Substantially Equivalent	Mentor Corp.
K002803	THE O'NEIL STERILE FIELD URINARY CATHETER KIT	Dec 27, 2000	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K983010	SELF CATH SET/SAFETY CATH	Feb 12, 1999	Substantially Equivalent	Rusch Intl.
K963993	RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET	Dec 17, 1996	Substantially Equivalent	Rusch, Inc.
K962254	NHMC URETHRAL CATHETERIZATION TRAY	Jul 29, 1996	Substantially Equivalent	National Healthcare Mfg. Corp.
K962073	URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY	Jun 21, 1996	Substantially Equivalent	Continental Medical Laboratories, Inc.
K961442	UNIVERSAL DRAINAGE TRAY	May 09, 1996	Substantially Equivalent	Customed, Inc.
K960215	CPR URETHRAL CATHETER TRAY	Apr 01, 1996	Substantially Equivalent	Custom Pack Reliability
K960214	CPR FOLEY CAHTETER KIT	Apr 01, 1996	Substantially Equivalent	Custom Pack Reliability
K960566	NHMC FOLEY CATHETERIZATION TRAY	Feb 29, 1996	Substantially Equivalent	National Healthcare Mfg. Corp.
K951479	CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE	Jun 15, 1995	Substantially Equivalent	Trinity Laboratories, Inc.
K950390	URETHRAL CATHETERIZATION TRAY	May 30, 1995	Substantially Equivalent	Medcare Custom Packaging, Inc.
K951178	UROLOGICAL CATHETER & ACCESSORIES	Apr 21, 1995	Substantially Equivalent	Deroyal Industries, Inc.
K950344	HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER	Mar 24, 1995	Unknown	Acacia Laboratories, Inc.
K950109	CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER	Feb 27, 1995	Unknown	Cypress Medical Products, Ltd.
K950092	CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY	Feb 27, 1995	Unknown	Cypress Medical Products, Ltd.
K942177	FOLEY CATHETERIZATION TRAY	Sep 08, 1994	Substantially Equivalent	Customed, Inc.
K923538	MON-A-THERM FOLEY KIT	May 27, 1993	Unknown	Mallinckrodt Medical
K910653	TOUCHLESS II INTERMITTENT CATHETER	May 06, 1991	Substantially Equivalent	C.R. Bard, Inc.
K910022	MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT	Apr 02, 1991	Unknown	Medical Marketing Group
K904158	ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY	Nov 29, 1990	Unknown	Welcon, Inc.
K903340	STERILE URETHRAL CATHETER PROCEDURE KITS	Oct 04, 1990	Unknown	Superior Healthcare Group, Inc.
K902508	LAKE MALE EXTERNAL CATHETERIZATION KIT	Aug 23, 1990	Unknown	Lake Medical Products, Inc.
K901185	FOLEY CATHETER INSERTION TRAY (10CC)	Jul 20, 1990	Unknown	Orion Life Systems, Inc.
K901184	URETHRAL CATHETER TRAY (LATEX)	Jul 20, 1990	Unknown	Orion Life Systems, Inc.
K901183	URETHRAL CATHETER TRAY (PVC)	Jul 20, 1990	Unknown	Orion Life Systems, Inc.
K901181	CATHETER CARE TRAY	Jul 20, 1990	Unknown	Orion Life Systems, Inc.
K901180	FOLEY CATHETER INSERTION TRAY (30CC)	Jul 20, 1990	Unknown	Orion Life Systems, Inc.
K896212	URETHRAL CATHETERIZATION TRAYS	Jan 24, 1990	Unknown	Westmark, Sterile Packing Systems, Inc. (Sps)
K790254	FOLEY CATHETERIZATION TRAY	Apr 10, 1979	Substantially Equivalent	Snyder Laboratories, Inc.
K790272	TRAY, URETHRAL CATHETERIZATION	Mar 06, 1979	Substantially Equivalent	Snyder Laboratories, Inc.
K790271	TRAY AND BAG, CATHETERIZATION	Mar 06, 1979	Substantially Equivalent	Snyder Laboratories, Inc.
K780879	URETHRO CATHETERIZATION TRAY	Jul 31, 1978	Substantially Equivalent	Abco Dealers, Inc.
K780735	URINARY CATHETER CARE SET	Jun 13, 1978	Substantially Equivalent	Shield Laboratories, Inc.
K772277	BLADDER RETENTION-CATHETHERIZATIONTRAY	Mar 02, 1978	Substantially Equivalent	Latex Ind., Inc.
K780268	BLADDER CATH KIT W/OUT CATHETER	Feb 24, 1978	Substantially Equivalent	Latex Ind., Inc.
K772342	ROBINSON KIT - 750014 & 750016	Feb 24, 1978	Substantially Equivalent	Latex Ind., Inc.
K772341	BLADDER KIT - 734000	Feb 24, 1978	Substantially Equivalent	Latex Ind., Inc.
K772340	CATHETERIZATION KIT 732016-732018	Feb 24, 1978	Substantially Equivalent	Latex Ind., Inc.
K780124	CATHETERIZATION PROCED. TRAY, URETHRAL	Feb 21, 1978	Substantially Equivalent	Walpak Co.
K780123	CATHETERIZATION PROCEDURE TRAY	Feb 21, 1978	Substantially Equivalent	Walpak Co.
K771652	CATH-CARE TRAY	Sep 20, 1977	Substantially Equivalent	Latex Ind., Inc.
K771651	AKRO-SIL FOLEY KIT 5CC	Sep 20, 1977	Substantially Equivalent	Latex Ind., Inc.
K771650	AKRO-SIL FOLEY KIT 30CC	Sep 20, 1977	Substantially Equivalent	Latex Ind., Inc.
K771104	URETHRAL TRAY W/OUT CAHTETER, 7650	Jun 24, 1977	Substantially Equivalent	Concord Laboratories, Inc.
K771103	URETHRAL TRAY W/CATHETER, 7750	Jun 24, 1977	Substantially Equivalent	Concord Laboratories, Inc.
K770496	UNIVERSAL TRAY	Mar 21, 1977	Substantially Equivalent	Concord Laboratories, Inc.
K760048	TRAY, URETHRAL CATHETERIZATION	Mar 01, 1977	Substantially Equivalent	M-C Ind., Inc.
K760128	TRAY, CATHETERIZATION W/ CATHETER	Oct 07, 1976	Substantially Equivalent	Concord Laboratories, Inc.
K760127	TRAY, CATHETERIZATION W/O CATHETER	Oct 07, 1976	Substantially Equivalent	Concord Laboratories, Inc.