# MSD: Catheter, Hemodialysis, Implanted

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 124
- 510(k) review time 2021–2025: median 206 days (middle half 100–210)
- Recalls: 137 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 5
- 2014: 8
- 2015: 1
- 2016: 2
- 2017: 2
- 2018: 2
- 2019: 1
- 2020: 4
- 2021: 4
- 2025: 1

## Most-cited predicates
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (2001), cited by 6
- K020465: Medcomp Ash Split-Cath II (2002), cited by 6
- K972207: Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM (1998), cited by 5
- K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter (2002), cited by 5
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter (2002), cited by 5
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) (2002), cited by 5
- K030020: Hemosplit Long-Term Hemodialysis Catheter (2003), cited by 4
- K981125: Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6 (1999), cited by 4
- K043272: Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (2004), cited by 4
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 (2003), cited by 4

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