# QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated

- Device class: 2; regulation: 21 CFR 862.1355; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 119 days (middle half 27–191)
- Recalls: 6 (1 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: 2
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 4
- 2024: 3
- 2025: 2
- 2026: 2

## Most-cited predicates
- DEN170088: Dexcom G6 Continuous Glucose Monitoring System (2018), cited by 4
- K240902: Dexcom G7 Continuous Glucose Monitoring System (2024), cited by 3
- K222447: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (2023), cited by 3
- K191450: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System (2019), cited by 3
- K201328: Dexcom G6 Continuous Glucose Monitoring (CGM) System (2021), cited by 2
- K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System (2025), cited by 2
- K231081: Dexcom G7 Continuous Glucose Monitoring (CGM) System (2023), cited by 2
- K200876: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (2020), cited by 2
- K223435: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (2023), cited by 1
- K253737: Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (2026), cited by 1

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