JGSClass II

Electrode, Ion Specific, Sodium

21 CFR 862.1665 / Clinical Chemistry

JGS is the FDA product code for Electrode, Ion Specific, Sodium, a class II device type, regulated under 21 CFR 862.1665. As of 2026-09-10, FDA records hold 162 510(k) clearances under this code, the most recent dated 2026-05-01, and 48 recalls.

Classification record

Product code: JGS
Device name: Electrode, Ion Specific, Sodium
Regulation: 21 CFR 862.1665
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: 162
Ingested recalls: 48

Clearances, product code JGS

By decision year

162 clearances under product code JGS with a decision year between 1977 and 2026, 1984 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code JGS by decision year
Year	Clearances
1977	2
1979	1
1980	10
1981	4
1982	2
1983	7
1984	11
1985	6
1986	7
1987	9
1988	7
1989	6
1990	5
1991	11
1992	6
1993	6
1994	3
1995	1
1996	7
1999	5
2000	4
2001	2
2002	2
2004	2
2005	3
2006	2
2008	2
2009	2
2010	1
2011	3
2012	1
2013	2
2014	1
2015	1
2016	4
2017	1
2018	3
2019	3
2020	2
2022	1
2023	3
2026	1

Applicants with the most clearances

Product code JGS

Applicants holding the most 510(k) clearances under product code JGS
Applicant	Clearances
Nova Biomedical Corporation	21
Medica Corp.	9
Siemens Healthcare Diagnostics Inc.	6
Abbott Medical	5
Instrumentation Laboratory Co.	5
American Research Products Co.	4
Ciba Corning Diagnostics Corp.	4
DIAMOND DIAGNOSTICS Inc	4
I-Stat Corp.	4
Roche Diagnostics GmbH	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order