CEMClass II

Electrode, Ion Specific, Potassium

21 CFR 862.1600 / Clinical Chemistry

CEM is the FDA product code for Electrode, Ion Specific, Potassium, a class II device type, regulated under 21 CFR 862.1600. As of 2026-09-10, FDA records hold 89 510(k) clearances under this code, the most recent dated 2026-02-12, and 63 recalls.

Classification record

Product code: CEM
Device name: Electrode, Ion Specific, Potassium
Regulation: 21 CFR 862.1600
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: 89
Ingested recalls: 63

Clearances, product code CEM

By decision year

89 clearances under product code CEM with a decision year between 1977 and 2026, 1984 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code CEM by decision year
Year	Clearances
1977	2
1979	3
1980	4
1981	1
1982	2
1983	4
1984	10
1985	10
1986	1
1987	2
1988	2
1989	3
1990	6
1991	1
1992	5
1993	1
1996	2
1997	1
1998	1
1999	1
2001	2
2003	1
2004	3
2006	4
2007	1
2009	1
2010	3
2011	3
2012	4
2020	1
2023	2
2025	1
2026	1

Applicants with the most clearances

Product code CEM

Applicants holding the most 510(k) clearances under product code CEM
Applicant	Clearances
Abbott Medical	4
Medica Corp.	4
Nova Biomedical Corporation	4
Roche Diagnostics GmbH	4
Avl Scientific Corp.	3
Siemens Healthcare Diagnostics Inc.	3
Boehringer Mannheim Corp.	3
Hi Chem, Inc.	3
American Research Products Co.	2
Baxter Healthcare Corporation	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order