FOSClass II

Catheter, Umbilical Artery

21 CFR 880.5200 / General Hospital

FOS is the FDA product code for Catheter, Umbilical Artery, a class II device type, regulated under 21 CFR 880.5200. As of 2026-09-10, FDA records hold 34 510(k) clearances under this code, the most recent dated 2021-05-06, and 7 recalls.

Classification record

Product code: FOS
Device name: Catheter, Umbilical Artery
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: 34
Ingested recalls: 7

Clearances, product code FOS

By decision year

34 clearances under product code FOS with a decision year between 1977 and 2021, 1994 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code FOS by decision year
Year	Clearances
1977	3
1980	1
1983	1
1984	1
1985	2
1989	1
1990	1
1991	1
1992	2
1994	7
1995	5
1996	1
1998	1
2008	2
2009	2
2012	1
2013	1
2021	1

Applicants with the most clearances

Product code FOS

Applicants holding the most 510(k) clearances under product code FOS
Applicant	Clearances
Gesco Intl., Inc.	6
Sherwood Medical Co.	6
Footprint Medical Inc.	3
C.R. Bard Inc	2
Halyard Health	2
Vygon Corp.	2
Axiom Medical, Inc.	1
Becton Dickinson Vascular Access, Inc.	1
Catheter Technology Corp.	1
Covidien Lp, Formerly Registered AS Kendall	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order