FCMClass II

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

21 CFR 876.5130 / Gastroenterology, Urology

FCM is the FDA product code for Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), a class II device type, regulated under 21 CFR 876.5130. As of 2026-09-10, FDA records hold 60 510(k) clearances under this code, the most recent dated 2026-05-29, and 43 recalls.

Classification record

Product code: FCM
Device name: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Regulation: 21 CFR 876.5130
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 60
Ingested recalls: 43

Clearances, product code FCM

By decision year

60 clearances under product code FCM with a decision year between 1976 and 2026, 1978 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code FCM by decision year
Year	Clearances
1976	2
1977	7
1978	9
1979	3
1990	9
1991	2
1993	1
1994	1
1995	6
1996	7
1999	1
2000	1
2001	3
2003	2
2007	2
2008	1
2023	1
2025	1
2026	1

Applicants with the most clearances

Product code FCM

Applicants holding the most 510(k) clearances under product code FCM
Applicant	Clearances
Latex Ind., Inc.	8
Concord Laboratories, Inc.	5
Orion Life Systems, Inc.	5
Amsino International, Inc.	3
Snyder Laboratories, Inc.	3
C.R. Bard Inc	2
MEDLINE INDUSTRIES, LP - Northfield	2
Custom Pack Reliability	2
Customed, Inc	2
Cypress Medical Products LLC	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order