# K133456: Power-Trialysis Short-Term Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 24, 2014 after 316 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter, C.R. Bard, Inc. (2009) Summary page 5.

## Most influential descendants
- K141531: Power-Trialysis Slim-Cath Short-Term Dialysis Catheter (2015), 1 descendant of its own
- K153190: Zenysis Short-Term Dialysis Catheter (2016), 0 descendants of its own

## Recalls of this device
- Aug 10, 2026 · Class I · Z-2984-2026: this is a downstream recall of class I recall RES 98777
- May 21, 2026 · Class II · Z-2660-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Sep 16, 2019 · Class II · Z-0285-2020: A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.

## Indications for use
The Power-Trialysis Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K133456
Methodology: https://510kreport.com/methodology