# OZP: Automated Insulin Dosing Device System, Single Hormonal Control

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- Recalls: 9 (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)
- 2017: 15
- 2018: 28
- 2019: 21
- 2020: 8
- 2021: 6
- 2022: 7
- 2023: 7
- 2024: 7
- 2025: 14
- 2026: 6

## Most-cited predicates

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