KFMClass II

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

21 CFR 870.4360 / Cardiovascular

KFM is the FDA product code for Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, a class II device type, regulated under 21 CFR 870.4360. As of 2026-09-10, FDA records hold 84 510(k) clearances under this code, the most recent dated 2025-08-04, and 40 recalls.

Classification record

Product code: KFM
Device name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation: 21 CFR 870.4360
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 84
Ingested recalls: 40

Clearances, product code KFM

By decision year

84 clearances under product code KFM with a decision year between 1977 and 2025, 2011 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code KFM by decision year
Year	Clearances
1977	1
1978	1
1984	1
1985	4
1986	1
1988	2
1989	2
1990	4
1991	2
1992	1
1993	2
1994	1
1995	1
1996	1
1997	1
1998	2
1999	1
2000	3
2001	2
2002	5
2003	5
2004	1
2005	3
2006	1
2008	4
2009	5
2010	3
2011	7
2013	2
2017	1
2019	3
2020	3
2021	3
2023	3
2025	2

Applicants with the most clearances

Product code KFM

Applicants holding the most 510(k) clearances under product code KFM
Applicant	Clearances
Medtronic, Inc.	8
Spectrum Medical Inc	7
Terumo Cardiovascular Systems Corporation	6
MAQUET CARDIOPULMONARY GmbH	5
3M Health Care, Sarns	4
Abiomed, Inc.	4
Cardiacassist, Inc.	4
3M Company	3
A-Med Systems, Inc.	3
Bio Medicus, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order