# QII: Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

- Device class: 2; regulation: 21 CFR 862.1355; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 0 (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)
- 2019: 1

## Most-cited predicates
- K191833: Dexcom G6 Pro Continuous Glucose Monitoring System (2019), cited by 1

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