# K110409: Aspira Pleural Drainage System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 11, 2011 after 86 days
- Product code: DWM (Apparatus, Suction, Patient Care)
- Device class: 2
- Regulation: 21 CFR 870.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971753 (1997). 6 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071095: Aspira Pleural Drainage System, Bard Access Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K112831: Pleurx Pleural Catheter Systems (2012), 6 descendants of its own
- K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B (2013), 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
- K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit (2015), 1 descendant of its own
- K212696: Aspira Pleural Drainage System (2023), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1599-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The Aspira® Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions. 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/K110409
Methodology: https://510kreport.com/methodology