KODClass II

Catheter, Urological

21 CFR 876.5130 / Gastroenterology, Urology

KOD is the FDA product code for Catheter, Urological, a class II device type, regulated under 21 CFR 876.5130. As of 2026-09-10, FDA records hold 238 510(k) clearances under this code, the most recent dated 2026-02-23, and 108 recalls.

Classification record

Product code: KOD
Device name: Catheter, Urological
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: 238
Ingested recalls: 108

Clearances, product code KOD

By decision year

238 clearances under product code KOD with a decision year between 1976 and 2026, 1986 the highest year at 24.

Show the numbers

510(k) clearances under FDA product code KOD by decision year
Year	Clearances
1976	5
1977	6
1978	4
1979	16
1980	18
1981	14
1982	13
1983	12
1984	16
1985	11
1986	24
1987	14
1988	10
1989	5
1990	16
1991	1
1992	6
1993	6
1994	3
1995	2
1997	1
2000	4
2001	2
2002	3
2003	1
2004	4
2008	2
2009	1
2010	1
2011	2
2014	1
2016	2
2017	1
2018	6
2019	1
2021	1
2022	2
2026	1

Applicants with the most clearances

Product code KOD

Applicants holding the most 510(k) clearances under product code KOD
Applicant	Clearances
C.R. Bard Inc	10
Cook Incorporated	10
Abco Dealers, Inc.	9
Van-Tec, Inc.	8
The Kendal Co.	7
American Pharmaseal Div. Ahsc	6
MEDLINE INDUSTRIES, LP - Northfield	6
Boston Scientific Corporation	5
Conphar, Inc.	5
Vance Products, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 88 companies shown, in name order