# K112831: Pleurx Pleural Catheter Systems

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Feb 16, 2012 after 141 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: 3 generations back to K971753 (1997). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051084: Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line, Denver Biomedicals, Inc. (2005) Summary page 1.
- K052436: Pleurx Pleural Catheter Kit, Model 50-7000, Denver Biomedical, Inc. (2005) Summary page 1.
- K110409: Aspira Pleural Drainage System, C.R. Bard, Inc. (2011) Summary page 1.

## Most influential descendants
- K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B (2013), 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
- K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit (2015), 1 descendant of its own
- K210509: Rocket Platinum Cured Cathter (2021), 0 descendants of its own
- K163321: Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (2017), 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, 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.

Source page: https://510kreport.com/device/K112831
Methodology: https://510kreport.com/methodology