FRNClass II

Pump, Infusion

21 CFR 880.5725 / General Hospital

FRN is the FDA product code for Pump, Infusion, a class II device type, regulated under 21 CFR 880.5725. As of 2026-09-10, FDA records hold 849 510(k) clearances under this code, the most recent dated 2026-07-24, and 720 recalls.

Classification record

Product code: FRN
Device name: Pump, Infusion
Regulation: 21 CFR 880.5725
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: No
Ingested clearances: 849
Ingested recalls: 721

Clearances, product code FRN

By decision year

849 clearances under product code FRN with a decision year between 1976 and 2026, 1990 the highest year at 54.

Show the numbers

510(k) clearances under FDA product code FRN by decision year
Year	Clearances
1976	3
1977	8
1978	4
1979	14
1980	14
1981	26
1982	26
1983	46
1984	33
1985	39
1986	36
1987	45
1988	39
1989	28
1990	54
1991	52
1992	26
1993	33
1994	24
1995	20
1996	13
1997	8
1998	18
1999	19
2000	20
2001	12
2002	16
2003	22
2004	20
2005	22
2006	13
2007	12
2008	8
2009	9
2010	3
2011	3
2012	4
2013	6
2014	6
2015	3
2016	3
2017	3
2018	3
2019	2
2020	1
2021	2
2022	6
2023	7
2024	5
2025	8
2026	2

Applicants with the most clearances

Product code FRN

Applicants holding the most 510(k) clearances under product code FRN
Applicant	Clearances
Abbott Medical	89
Baxter Healthcare Corporation	51
Travenol Laboratories, S.A.	23
C.R. Bard Inc	22
Medtronic, Inc.	20
Y	18
3M Avi, Inc.	16
3M Company	16
Imed Corp.	16
BD Becton Dickinson Vacutainer Systems Preanalytic	14

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 119 companies shown, in name order