# QNS: Low Dead Space Needle, Single Lumen, Hypodermic

- Device class: 2; regulation: 21 CFR 880.5570; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 30 days (middle half 15–149)
- 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
- 2024: 2

## Most-cited predicates
- K210444: EZ-Injec LDV Sterile Safety Needle (2021), cited by 5

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