# K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Oct 18, 2012 after 115 days
- Product code: DWM (Apparatus, Suction, Patient Care)
- Device class: 2
- Regulation: 21 CFR 870.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932323 (1993). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112831: Pleurx Pleural Catheter Systems, Care Fusion (2012) Summary page 1.
- K113854: Pleurx Peritoneal Catheter System, Care Fusion (2012) Summary page 1.
- K110409: Aspira Pleural Drainage System, C.R. Bard, Inc. (2011) Summary page 1.
- K090394: Valved Tearway Introducer, Medcomp (2009) Summary page 1.
- K040150: Modification to Medamicus Flowguard Peelable Introducer, Medamicus, Inc. (2004) Summary page 1.

## Most influential descendants
- K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit (2015), 1 descendant of its own
- K160450: Pleurx Pleural Catheter System (2016), 0 descendants of its own

## Indications for use
The Pleurx Pldural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion). The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 Dressing Kits are indicated for dressing of a catheter and exit site. The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance. The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the pleural space. The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.

Source page: https://510kreport.com/device/K121849
Methodology: https://510kreport.com/methodology