# QNQ: Low Dead Space Piston Syringe

- Device class: 2; regulation: 21 CFR 880.5860; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 194 days (middle half 93–315)
- 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: 2
- 2024: 4
- 2025: 2
- 2026: 1

## Most-cited predicates
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe (2021), cited by 5
- K232943: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (2024), cited by 2
- K242291: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle (2024), cited by 2
- K231856: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (2024), cited by 1
- K221860: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe (2023), cited by 1
- K213010: FEELject LDV (Low dead volume) syringe (2023), cited by 1

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