FDA Product Code FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Leading manufacturers include C.R. Bard, Inc., Coloplast and Convatec Limited.
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
Cleared
May 29, 2026
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
C.R. Bard, Inc.
Gastroenterology & Urology
162d
Cleared
Jun 06, 2025
Cure Catheter Insertion Kit (K1)
Convatec Limited
Gastroenterology & Urology
73d
Cleared
Aug 02, 2023
Self-Cath Closed System
Coloplast
Gastroenterology & Urology
224d
Cleared
May 06, 1991
TOUCHLESS II INTERMITTENT CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
81d
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 →