# QRX: Continuous Glucose Monitor Informed Insulin Dose Calculator

- Device class: 2; regulation: 21 CFR 862.1358; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 119 days (middle half 75–322)
- Recalls: 1 (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)
- 2022: 2
- 2023: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K203772: Omnipod 5 SmartBolus Calculator (2022), cited by 2
- K222239: SmartBolus Calculator (2022), cited by 1
- K222888: BlueStar CGM insulin dose calculator (2023), cited by 1
- K252818: Dexcom Smart Basal (2025), cited by 1

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