# K011831: Modification to Pleurx Pleural Catheter and Drainage Kits

- Pathway: 510(k) (Special)
- Applicant: Denver Biomedical, Inc.
- Decided: Jun 28, 2001 after 16 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Denver Pleurx Pleural Catheter: named in the summary without a submission number

## Most influential descendants
- K071095: Aspira Pleural Drainage System (2007), 9 descendants of its own
- K110409: Aspira Pleural Drainage System (2011), 8 descendants of its own
- K112831: Pleurx Pleural Catheter Systems (2012), 6 descendants of its own
- K093307: Asept Pleural Drainage System (2009), 4 descendants of its own
- K093796: Asept Peritoneal Drainage System (2010), 3 descendants of its own

## Indications for use
The Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are indicated for intermittent, long-term drainage of symptomatic, recurrent pleural effusions, including malignant pleural effusions 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).

Source page: https://510kreport.com/device/K011831
Methodology: https://510kreport.com/methodology