# CGZ: Electrode, Ion-Specific, Chloride

- Device class: 2; regulation: 21 CFR 862.1170; FDA's rule: 510(k) required
- FDA decisions: 38
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 2
- 2001: 3
- 2002: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2008: 2
- 2016: 1
- 2017: 1
- 2018: 1

## Most-cited predicates
- K000926: Easyelectrolyte Analyzer and Rapidlyte Analyzer (2000), cited by 4
- K003668: Autodelfia Neonatal Irt Kit, Model B005-112 (2001), cited by 3
- K980367: Aeroset System (1998), cited by 3
- K981270: Irma Blood Analysis System (1998), cited by 2
- K170320: Alinity c ICT Sample Diluent (2017), cited by 1
- K912647: ISE/CI- (1991), cited by 1
- K082099: Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131 4905 (2008), cited by 1
- K162020: VITROS Chemistry Products Cl- Slides (2016), cited by 1
- K182072: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (2018), cited by 1

Source page: https://510kreport.com/product-code/CGZ
Data by year (CSV): https://510kreport.com/product-code/CGZ.csv