CHLClass II

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

21 CFR 862.1120 / Clinical Chemistry

CHL is the FDA product code for Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a class II device type, regulated under 21 CFR 862.1120. As of 2026-09-10, FDA records hold 188 510(k) clearances under this code, the most recent dated 2026-04-10, and 184 recalls.

Classification record

Product code: CHL
Device name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation: 21 CFR 862.1120
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 188
Ingested recalls: 184

Clearances, product code CHL

By decision year

188 clearances under product code CHL with a decision year between 1976 and 2026, 1983 the highest year at 19.

Show the numbers

510(k) clearances under FDA product code CHL by decision year
Year	Clearances
1976	2
1977	6
1978	1
1979	2
1980	3
1981	6
1982	4
1983	19
1984	7
1985	7
1986	2
1987	3
1988	5
1989	4
1990	5
1991	2
1992	5
1993	2
1994	11
1995	8
1996	7
1997	3
1998	6
1999	4
2000	7
2001	2
2002	7
2003	1
2004	1
2005	3
2006	1
2007	1
2008	1
2010	1
2011	4
2012	4
2013	5
2014	3
2015	4
2016	3
2017	1
2018	1
2020	4
2021	2
2023	5
2024	1
2025	1
2026	1

Applicants with the most clearances

Product code CHL

Applicants holding the most 510(k) clearances under product code CHL
Applicant	Clearances
Nova Biomedical Corporation	28
Instrumentation Laboratory Co.	16
Fisher Scientific Company L.L.C.	15
Radiometer America, Inc	15
Radiometer Medical ApS	14
Avl Scientific Corp.	12
Ciba Corning Diagnostics Corp.	7
Shaban Mfg. Co.	6
Abbott Medical	4
Corning Medical & Scientific	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order