FPAClass II

Set, Administration, Intravascular

21 CFR 880.5440 / General Hospital

FPA is the FDA product code for Set, Administration, Intravascular, a class II device type, regulated under 21 CFR 880.5440. As of 2026-09-10, FDA records hold 1,174 510(k) clearances under this code, the most recent dated 2026-06-03, and 1,085 recalls.

Classification record

Product code: FPA
Device name: Set, Administration, Intravascular
Regulation: 21 CFR 880.5440
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: 1,175
Ingested recalls: 1,089

Clearances, product code FPA

By decision year

1,175 clearances under product code FPA with a decision year between 1976 and 2026, 1995 the highest year at 51.

Show the numbers

510(k) clearances under FDA product code FPA by decision year
Year	Clearances
1976	3
1977	19
1978	24
1979	17
1980	20
1981	24
1982	25
1983	34
1984	48
1985	43
1986	37
1987	26
1988	25
1989	36
1990	37
1991	25
1992	24
1993	38
1994	36
1995	51
1996	34
1997	41
1998	22
1999	36
2000	27
2001	40
2002	32
2003	29
2004	27
2005	20
2006	12
2007	16
2008	18
2009	10
2010	23
2011	12
2012	21
2013	13
2014	22
2015	15
2016	12
2017	17
2018	4
2019	7
2020	10
2021	13
2022	14
2023	14
2024	7
2025	11
2026	4

Applicants with the most clearances

Product code FPA

Applicants holding the most 510(k) clearances under product code FPA
Applicant	Clearances
Abbott Medical	78
Baxter Healthcare Corporation	67
Sterling Medivations, Inc.	24
B.Braun Medical, Inc.	22
Travenol Laboratories, S.A.	21
Medtronic, Inc.	16
Churchill Corp.	15
Y	15
Nexus Medical, LLC	14
Quest Medical, Inc	12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 367 companies shown, in name order