# QJI: Interoperable Automated Glycemic Controller

- Device class: 2; regulation: 21 CFR 862.1356; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 176 days (middle half 78–267)
- 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
- 2020: 1
- 2022: 2
- 2023: 4
- 2024: 4
- 2025: 5
- 2026: 8

## Most-cited predicates
- K200467: Control-IQ Technology (2020), cited by 4
- DEN190034: Control-IQ Technology (2019), cited by 2
- K232382: Control-IQ Technology (2023), cited by 2
- K251217: SmartGuard technology; Predictive Low Glucose technology (2025), cited by 2
- K203689: Tidepool Loop (2023), cited by 2
- K232741: SmartAdjust (TM) technology (2024), cited by 1
- K232224: iLet® Dosing Decision Software (2023), cited by 1
- K243823: Control-IQ+ technology (2025), cited by 1
- K220916: iLet® Dosing Decision Software (2023), cited by 1
- K251779: Omnipod 5 algorithm (2025), cited by 1

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