# K051084: Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line

- Pathway: 510(k) (Special)
- Applicant: Denver Biomedicals, Inc.
- Decided: Jun 13, 2005 after 46 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; 3 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 Drainage Kit: 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 Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle 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).

Source page: https://510kreport.com/device/K051084
Methodology: https://510kreport.com/methodology