# K212696: Aspira Pleural Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 3, 2023 after 555 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: 3 generations back to K971753 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110409: Aspira Pleural Drainage System, C.R. Bard, Inc. (2011) Summary page 4.

## Indications for use
The Aspira Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity forth purpose of relieving symptoms associated with pleural effusion. • Aspira Drainage Catheter: The Aspira Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access of the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusions and other recurrent effusions. • Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for intermittent drainage. • Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage. • Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site. • Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with silicone catheters with inner diameters between 0.103" - 0.116 such as the Aspira, Asept®, PleurX® and Rocket® catheters. • Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. • Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.

Source page: https://510kreport.com/device/K212696
Methodology: https://510kreport.com/methodology