# QOI: Intravenous Catheter Force-Activated Separation Device.

- Device class: 2; regulation: 21 CFR 880.5220; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 93 days (middle half 85–146)
- 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)
- 2021: 1
- 2022: 2
- 2023: 4
- 2024: 1

## Most-cited predicates
- DEN190043: SafeBreak Vascular (2021), cited by 2
- K232094: Orchid Safety Release ValveTM (2023), cited by 1
- K212064: Orchid Safety Release Valve (TM) (2022), cited by 1
- K230266: Orchid Safety Release Valve (2023), cited by 1
- K222791: SafeBreak Vascular (2022), cited by 1
- K223486: SafeBreak® Vascular (2023), cited by 1

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