# K071095: Aspira Pleural Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: May 18, 2007 after 30 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
Longest line of descent: 1 generation back to K971753 (1997). 5 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K971753: Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home Drainage Kit, Catalog NO. 50-7500, Denver Biomaterials, Inc. (1997) Summary page 1.
- K010642: Pleurx Pleural Catheter and Drainage Kits, Denver Biomedicals, Inc. (2001) Summary page 1.
- K011831: Modification to Pleurx Pleural Catheter and Drainage Kits, Denver Biomedical, Inc. (2001) Summary page 1.
- K051084: Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line, Denver Biomedicals, Inc. (2005) Summary page 1.
- K052436: Pleurx Pleural Catheter Kit, Model 50-7000, Denver Biomedical, Inc. (2005) Summary page 1.

## Most influential descendants
- K110409: Aspira Pleural Drainage System (2011), 8 descendants of its own
- 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

## Indications for use
The AspiraTM 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 AspiraTM Drainage Bag is indicated for use only with the AspiraTM Drainage Catheter for intermittent drainage. The AspiraTM Dressing Kit is indicated for dressing of a catheter and exit site. The Aspira TM Luer Adapter is intended to provide access to the AspiraTM Drainage Catheter. It is used to drain fluid using standard wall suction, syringe or other appropriate method. The AspiraTM Valve Assembly attaches to the Aspira TM Drainage Catheter. The AspiraTM Repair Kit is for the repair of the AspiraTM Drainage Catheter and replacement of the AspiraTm Valve.

Source page: https://510kreport.com/device/K071095
Methodology: https://510kreport.com/methodology