# K113854: Pleurx Peritoneal Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Mar 19, 2012 after 81 days
- Product code: PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081288 (2008). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits, Denver Biomedical, Inc. (2005) Summary page 4.
- K110396: Aspira Peritoneal Drainage System, C.R. Bard, Inc. (2011) Summary page 4.

## Most influential descendants
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), 4 descendants of its own
- K160437: PleurX Peritoneal Catheter System (2016), 2 descendants of its own
- K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee (2012), 2 descendants of its own
- K201155: PleurX Peritoneal Catheter System (2020), 1 descendant of its own
- K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit (2015), 1 descendant of its own

## Indications for use
The Pleurx Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only. The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage. The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site. The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.

Source page: https://510kreport.com/device/K113854
Methodology: https://510kreport.com/methodology