# K110396: Aspira Peritoneal Drainage System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 6, 2011 after 84 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: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081288 (2008). 1 ancestor in all.
10 later devices descend from it; 4 cite 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)
- K081288: Aspira Peritoneal Drainage System, C.R. Bard, Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K201155: PleurX Peritoneal Catheter System (2020), 1 descendant of its own

## Recalls of this device
- Apr 22, 2023 · Class II · Z-1915-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1911-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1913-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1916-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1912-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1920-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1918-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1914-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1909-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1910-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1917-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1908-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- Apr 22, 2023 · Class II · Z-1919-2023: There is a potential that valve assemblies will not open. preventing fluid from draining.
- May 21, 2011 · Not classified · Z-2962-2011: Labeling for drainage kit contained incomplete information.
- May 21, 2011 · Not classified · Z-2959-2011: Labeling for drainage kit contained incomplete information.
- May 21, 2011 · Not classified · Z-2961-2011: Labeling for drainage kit contained incomplete information.
- May 21, 2011 · Not classified · Z-2960-2011: Labeling for drainage kit contained incomplete information.

## 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/Universal 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/K110396
Methodology: https://510kreport.com/methodology