DTNClass II

Reservoir, Blood, Cardiopulmonary Bypass

21 CFR 870.4400 / Cardiovascular

DTN is the FDA product code for Reservoir, Blood, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4400. As of 2026-09-10, FDA records hold 169 510(k) clearances under this code, the most recent dated 2025-12-22, and 47 recalls.

Classification record

Product code: DTN
Device name: Reservoir, Blood, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4400
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: Yes
Ingested clearances: 169
Ingested recalls: 47

Clearances, product code DTN

By decision year

169 clearances under product code DTN with a decision year between 1976 and 2025, 1985 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code DTN by decision year
Year	Clearances
1976	1
1977	2
1978	2
1979	1
1980	2
1981	4
1982	5
1983	5
1984	8
1985	10
1986	3
1987	9
1988	5
1989	4
1990	7
1991	4
1992	6
1993	6
1994	7
1995	2
1996	3
1997	7
1998	6
1999	7
2000	5
2001	4
2002	2
2003	7
2004	2
2005	3
2006	2
2007	2
2008	1
2009	7
2010	1
2011	2
2013	4
2014	3
2015	2
2017	2
2023	1
2024	2
2025	1

Applicants with the most clearances

Product code DTN

Applicants holding the most 510(k) clearances under product code DTN
Applicant	Clearances
Gish Biomedical, Inc.	16
Shiley, Inc.	14
American Bentley	11
C.R. Bard Inc	10
Medtronic, Inc.	10
LivaNova USA, Inc.	9
Sorin Biomedical, Inc.	8
Corcym Inc.	8
MAQUET CARDIOPULMONARY GmbH	7
Bentley Laboratories, Inc.	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order