# K010642: Pleurx Pleural Catheter and Drainage Kits

- Pathway: 510(k) (Traditional)
- Applicant: Denver Biomedicals, Inc.
- Decided: Mar 20, 2001 after 15 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010642
Methodology: https://510kreport.com/methodology