# QLG: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

- Device class: 2; regulation: 21 CFR 862.1355; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 226 days (middle half 148–291)
- Recalls: 5 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2020: 1
- 2021: 4
- 2022: 2
- 2023: 2

## Most-cited predicates
- K210943: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (2021), cited by 3
- K193371: FreeStyle Libre 2 Flash Glucose Monitoring System (2020), cited by 3
- K201761: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (2021), cited by 2
- K212132: FreeStyle Libre 3 Continuous Glucose Monitoring System (2022), cited by 1
- K213996: FreeStyle Libre 3 Continuous Glucose Monitoring System (2022), cited by 1
- K202145: Bigfoot Unity Diabetes Management System (2021), cited by 1

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