# QJY: Infusion Pump, Drug Specific, Pharmacy-Filled

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 81 days (middle half 55–107)
- 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)
- 2020: 2
- 2024: 2

## Most-cited predicates
- K191313: Unity Subcutaneous Infusion System for Remodulin (2020), cited by 2
- K202690: Remunity Pump for Remodulin (treprostinil) Injection (2020), cited by 1

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