# K081288: Aspira Peritoneal Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 18, 2008 after 72 days
- Product code: PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits, Denver Biomedical, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K110396: Aspira Peritoneal Drainage System (2011), 10 descendants of its own
- K113854: Pleurx Peritoneal Catheter System (2012), 8 descendants of its own
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), 4 descendants of its own
- K160437: PleurX Peritoneal Catheter System (2016), 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

## Indications for use
The Aspira® Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage. The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site. The Aspira® Luer Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method. The Aspira® Valve Assembly attaches to the Aspira® Drainage Catheter. The Aspira® Repair Kit is for the repair of the Aspira® Drainage Catheter and replacement of the Aspira® Valve Assembly.

Source page: https://510kreport.com/device/K081288
Methodology: https://510kreport.com/methodology