# QFG: Alternate Controller Enabled Insulin Infusion Pump

- Device class: 2; regulation: 21 CFR 880.5730; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 98 days (middle half 44–266)
- Recalls: 13 (3 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: 2
- 2020: 1
- 2022: 2
- 2023: 9
- 2024: 5
- 2025: 5
- 2026: 6

## Most-cited predicates
- K191679: Omnipod DASH Insulin Management System with interoperable technology (2019), cited by 4
- K251032: MiniMed 780G insulin pump (2025), cited by 3
- DEN180058: t:slim X2 insulin pump with interoperable technology (2019), cited by 3
- K201214: t:slim X2 Insulin Pump with Interoperable Technology (2020), cited by 2
- K233952: DEKA ACE Pump System (2024), cited by 2
- K203234: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (2022), cited by 2
- K232380: t:slim X2 Insulin Pump with Interoperable Technology (2023), cited by 2
- K250930: twiist system (2025), cited by 1
- K240309: Tandem Mobi insulin pump with interoperable technology (2024), cited by 1
- K223846: iLet® ACE Pump (2023), cited by 1

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