FOZClass II

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

21 CFR 880.5200 / General Hospital

FOZ is the FDA product code for Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a class II device type, regulated under 21 CFR 880.5200. As of 2026-09-10, FDA records hold 507 510(k) clearances under this code, the most recent dated 2026-08-10, and 394 recalls.

Classification record

Product code: FOZ
Device name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation: 21 CFR 880.5200
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 508
Ingested recalls: 394

Clearances, product code FOZ

By decision year

508 clearances under product code FOZ with a decision year between 1976 and 2026, 1995 the highest year at 26.

Show the numbers

510(k) clearances under FDA product code FOZ by decision year
Year	Clearances
1976	2
1977	7
1978	3
1979	5
1980	6
1981	5
1982	14
1983	12
1984	13
1985	17
1986	16
1987	6
1988	14
1989	14
1990	22
1991	12
1992	10
1993	9
1994	17
1995	26
1996	16
1997	18
1998	12
1999	11
2000	16
2001	15
2002	7
2003	10
2004	9
2005	5
2006	8
2007	6
2008	9
2009	9
2010	3
2011	6
2012	13
2013	4
2014	9
2015	10
2016	9
2017	9
2018	1
2019	8
2020	10
2021	4
2022	8
2023	9
2024	6
2025	11
2026	7

Applicants with the most clearances

Product code FOZ

Applicants holding the most 510(k) clearances under product code FOZ
Applicant	Clearances
Becton Dickinson Infusion Therapy Systems Inc.	30
Menlo Care, Inc.	22
Parke-Davis Co.	14
Abbott Medical	12
B.Braun Medical, Inc.	12
Becton Dickinson Vascular Access, Inc.	11
BD Becton Dickinson Vacutainer Systems Preanalytic	10
Cook Inc.	10
C.R. Bard Inc	9
Togo Medikit Co., Ltd.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 168 companies shown, in name order