# QDK: Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

- Device class: 2; regulation: 21 CFR 862.1355; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 308 days (middle half 308–308)
- 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)
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K203089: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (2021), cited by 1
- K192787: Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System (2019), cited by 1
- K182041: Dexcom G6 Glucose Program Continuous Glucose Monitoring System (2018), cited by 1

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