# NQJ: Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 42 days (middle half 35–48)
- 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)
- 2003: 1
- 2004: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K031689: Dual Lumen Extended Length Catheter (Delc) (2003), cited by 2
- K041791: 5.2F Dual Lumen Extended Length Catheter (Delc) (2004), cited by 1
- K233515: Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (2023), cited by 1

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