# QCC: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

- Device class: 2; regulation: 21 CFR 862.1358; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 122 days (middle half 75–168)
- 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)
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K201476: DreaMed Advisor Pro (2020), cited by 2
- DEN170043: DreaMed Advisor Pro (2018), cited by 1
- K191370: DreaMed Advisor Pro (2019), cited by 1
- K210561: Advisor Pro Platform (2021), cited by 1

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