CCKClass II

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

21 CFR 868.1400 / Anesthesiology

CCK is the FDA product code for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a class II device type, regulated under 21 CFR 868.1400. As of 2026-09-10, FDA records hold 307 510(k) clearances under this code, the most recent dated 2026-08-12, and 84 recalls.

Classification record

Product code: CCK
Device name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation: 21 CFR 868.1400
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 307
Ingested recalls: 84

Clearances, product code CCK

By decision year

307 clearances under product code CCK with a decision year between 1977 and 2026, 1988 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code CCK by decision year
Year	Clearances
1977	4
1978	2
1979	3
1980	2
1981	2
1983	7
1984	9
1985	9
1986	10
1987	11
1988	16
1989	14
1990	8
1991	8
1992	8
1993	13
1994	12
1995	13
1996	5
1997	7
1998	10
1999	4
2000	6
2001	11
2002	4
2003	7
2004	8
2005	6
2006	3
2007	5
2008	3
2009	3
2010	3
2011	2
2012	7
2013	4
2014	9
2015	5
2016	2
2017	5
2018	6
2019	7
2020	4
2021	4
2022	3
2023	4
2024	3
2025	3
2026	3

Applicants with the most clearances

Product code CCK

Applicants holding the most 510(k) clearances under product code CCK
Applicant	Clearances
Oridion Medical 1987 Ltd.	17
GE Healthcare	14
Salter Labs	10
Datex Division Instrumentarium Corp.	9
Nihon Kohden America Inc	9
Biochem International, Inc.	6
Hewlett-Packard Co.	6
Nihon Kohden Corp.	6
Draeger, Inc.	5
Fenem, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 199 companies shown, in name order