# CGL: Electrode, Ion Based, Enzymatic, Creatinine

- Device class: 2; regulation: 21 CFR 862.1225; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 7 (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)
- 1991: 1
- 1997: 1
- 1999: 1
- 2006: 1
- 2007: 1
- 2012: 1
- 2017: 1
- 2026: 1

## Most-cited predicates
- K171059: Nova StatSensor Creatinine Hospital Meter System (2017), cited by 2
- K973292: I-Stat System (1997), cited by 1
- K113726: Epoc Chloride Test and Epoc Creatinine Test (2012), cited by 1
- K070068: Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips (2007), cited by 1

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