# K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Jul 2, 2015 after 346 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: 6 generations back to K932323 (1993). 22 ancestors in all.
1 later device descends 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)
- K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee, Care Fusion (2012) Summary page 4.

## Most influential descendants
- K160450: Pleurx Pleural Catheter System (2016), 0 descendants of its own

## Indications for use
The Pleurx Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, mcluding 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 Catheter Access Kit is intended to provide access to the Pleurx Catheter to inject or withdraw fluids

Source page: https://510kreport.com/device/K141965
Methodology: https://510kreport.com/methodology