FCM · Class II · 21 CFR 876.5130

FDA Product Code FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

Leading manufacturers include Concord Laboratories, Inc., Orion Life Systems, Inc. and Amsino International, Inc..

60
Total
60
Cleared
79d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 118d recently vs 78d historically

FDA 510(k) Cleared Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) Devices (Product Code FCM)

60 devices
1–24 of 60
Cleared May 29, 2026
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
K254076
C.R. Bard, Inc.
Gastroenterology & Urology · 162d
Cleared Jun 06, 2025
Cure Catheter Insertion Kit (K1)
K250891
Convatec Limited
Gastroenterology & Urology · 73d
Cleared Aug 02, 2023
Self-Cath Closed System
K223821
Coloplast
Gastroenterology & Urology · 224d
Cleared Oct 23, 2008
AMSELF CLOSED CATHETERIZATION SYSTEM
K082831
Amsino International, Inc.
Gastroenterology & Urology · 27d
Cleared May 23, 2003
AMSURE FOLEY INSERTION TRAY
K030664
Amsino International, Inc.
Gastroenterology & Urology · 81d
Cleared May 23, 2003
AMSURE URETHRAL CATHETERIZATION TRAY
K030712
Amsino International, Inc.
Gastroenterology & Urology · 78d
Cleared May 09, 2001
RUSCH MMG/O'NEIL CATHETER
K010420
Rusch, Inc.
Gastroenterology & Urology · 86d
Cleared Mar 29, 2001
MENTOR SELF-CATH CLOSED SYSTEM
K003873
Mentor Corp.
Gastroenterology & Urology · 104d
Cleared Feb 12, 1999
SELF CATH SET/SAFETY CATH
K983010
Rusch Intl.
Gastroenterology & Urology · 168d
Cleared Dec 17, 1996
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
K963993
Rusch, Inc.
Gastroenterology & Urology · 74d
Cleared Jul 29, 1996
NHMC URETHRAL CATHETERIZATION TRAY
K962254
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 47d
Cleared Jun 21, 1996
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
K962073
Continental Medical Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared May 09, 1996
UNIVERSAL DRAINAGE TRAY
K961442
Customed, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 01, 1996
CPR FOLEY CAHTETER KIT
K960214
Custom Pack Reliability
Gastroenterology & Urology · 76d
Cleared Apr 01, 1996
CPR URETHRAL CATHETER TRAY
K960215
Custom Pack Reliability
Gastroenterology & Urology · 76d
Cleared Feb 29, 1996
NHMC FOLEY CATHETERIZATION TRAY
K960566
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 20d
Cleared Jun 15, 1995
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479
Trinity Laboratories, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 21, 1995
UROLOGICAL CATHETER & ACCESSORIES
K951178
Deroyal Industries, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 27, 1995
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
K950092
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 48d
Cleared Feb 27, 1995
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
K950109
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 47d
Cleared Sep 08, 1994
FOLEY CATHETERIZATION TRAY
K942177
Customed, Inc.
Gastroenterology & Urology · 127d
Cleared May 27, 1993
MON-A-THERM FOLEY KIT
K923538
Mallinckrodt Medical
Gastroenterology & Urology · 315d
Cleared May 06, 1991
TOUCHLESS II INTERMITTENT CATHETER
K910653
C.R. Bard, Inc.
Gastroenterology & Urology · 81d
Cleared Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (30CC)
K901180
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d

About Product Code FCM - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code FCM since 1976, with 60 receiving FDA clearance (average review time: 79 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FCM Product Code

Recent submissions under FCM have taken an average of 118 days to reach a decision - up from 78 days historically. Manufacturers should account for longer review timelines in current project planning.

FCM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →