# NIE: Catheter, Hemodialysis, Triple Lumen, Non-Implanted

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 117 days (middle half 87–146)
- Recalls: 11 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 1
- 2004: 1
- 2009: 1
- 2010: 1
- 2013: 1
- 2014: 1
- 2015: 2
- 2018: 1
- 2019: 1
- 2023: 2

## Most-cited predicates
- K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter (2009), cited by 4
- K020089: Mahurkar Triple Lumen Catheter, 12 FR (2002), cited by 4
- K102605: Mahurkar Triple Lumen Dialysis Catheter (2010), cited by 4
- K033570: Medcomp T-3 (2004), cited by 2
- K183219: Trio-CT Triple Lumen Catheter (2019), cited by 1
- K141531: Power-Trialysis Slim-Cath Short-Term Dialysis Catheter (2015), cited by 1
- K123292: T3 (2013), cited by 1
- K133456: Power-Trialysis Short-Term Dialysis Catheter (2014), cited by 1

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