DRYClass II

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

21 CFR 870.4330 / Cardiovascular

DRY is the FDA product code for Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4330. As of 2026-09-10, FDA records hold 47 510(k) clearances under this code, the most recent dated 2024-04-25, and 40 recalls.

Classification record

Product code: DRY
Device name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4330
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: 47
Ingested recalls: 40

Clearances, product code DRY

By decision year

47 clearances under product code DRY with a decision year between 1981 and 2024, 1986 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code DRY by decision year
Year	Clearances
1981	1
1982	1
1983	2
1984	2
1985	1
1986	4
1987	2
1988	2
1990	3
1991	1
1992	2
1993	1
1995	1
1996	2
1997	2
1998	1
2000	1
2001	1
2006	1
2007	2
2009	2
2011	2
2012	1
2014	2
2017	1
2018	3
2020	1
2021	1
2024	1

Applicants with the most clearances

Product code DRY

Applicants holding the most 510(k) clearances under product code DRY
Applicant	Clearances
Spectrum Medical Inc	9
Terumo Cardiovascular Systems Corporation	4
3M Company	3
3M Healthcare	2
Cardiovascular Devices, Inc.	2
International Biophysics Corp.	2
LivaNova Deutschland GmbH	2
Medtronic, Inc.	2
3M Company	1
American Bentley	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order