# K160450: Pleurx Pleural Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Oct 31, 2016 after 256 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: 7 generations back to K932323 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Care Fusion (2015) Summary page 4.
- K110409: Aspira Pleural Drainage System, C.R. Bard, Inc. (2011) Summary page 4.

## Indications for use
The PleurX Pleural 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 Pleural Catheter Kits are indicated for adults only. The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method. The PleurX Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated for adults only. The PleurX LP Catheter Mini Kit is 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 the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.

Source page: https://510kreport.com/device/K160450
Methodology: https://510kreport.com/methodology