# OPP: Pump, Infusion, Insulin Bolus

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 60 days (middle half 44–75)
- 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)
- 2010: 2
- 2012: 1
- 2017: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- K163357: OneTouch Via On-Demand Insulin Delivery System (2017), cited by 3
- K093065: Finesse Personal Insulin Delivery Patch, Model FG-2000 (2010), cited by 3
- K233447: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), cited by 2
- K100947: Finesse Personal Insulin Delivery Patch, Model FG 2000 (2010), cited by 2
- K111924: Finesse Personal Insulin Delivery Patch (2012), cited by 1
- K243273: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), cited by 1

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