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., C.R. Bard, Inc. and Customed, 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 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 May 09, 1996
UNIVERSAL DRAINAGE TRAY
K961442
Customed, Inc.
Gastroenterology & Urology · 24d
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 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 31, 1978
URETHRO CATHETERIZATION TRAY
K780879
Abco Dealers, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 24, 1977
URETHRAL TRAY W/CATHETER, 7750
K771103
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Jun 24, 1977
URETHRAL TRAY W/OUT CAHTETER, 7650
K771104
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Mar 21, 1977
UNIVERSAL TRAY
K770496
Concord Laboratories, Inc.
Gastroenterology & Urology · 7d
Cleared Oct 07, 1976
TRAY, CATHETERIZATION W/O CATHETER
K760127
Concord Laboratories, Inc.
Gastroenterology & Urology · 101d
Cleared Oct 07, 1976
TRAY, CATHETERIZATION W/ CATHETER
K760128
Concord Laboratories, Inc.
Gastroenterology & Urology · 101d

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 →