# MPB: Catheter, Hemodialysis, Non-Implanted

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 145 days (middle half 145–145)
- Recalls: 10 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 3
- 2009: 1
- 2010: 1
- 2011: 2
- 2012: 1
- 2013: 1
- 2016: 1
- 2017: 2
- 2020: 3
- 2025: 1

## Most-cited predicates
- K010778: Niagara Slim-Cath (2001), cited by 5
- K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro (2000), cited by 5
- K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB (1999), cited by 4
- K965178: Niagara Dual Lumen Catheter (1997), cited by 3
- K030209: Mahurkar Oplus Catheter, Model 13.5 FR (2003), cited by 3
- K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin (1999), cited by 3
- K070234: JMS Sysloc Mini Avf and Apheresis Needle Sets (2007), cited by 2
- K071145: Nipro Safetouch Tulip Safety Fistula Needle (2007), cited by 2
- K120674: Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter (2012), cited by 1
- K192807: Duo-Flow Side x Side Double Lumen Catheter (2020), cited by 1

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