# K212675: Aspira Peritoneal Drainage System

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 14, 2021 after 112 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: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081288 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110396: Aspira Peritoneal Drainage System, C.R. Bard, Inc. (2011) Summary page 4.

## 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.

## Indications for use
The Aspira Peritoneal Drainage System 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. •Aspira Drainage Catheter: The Aspira Drainage catheter 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 relieves symptoms such as dyspnea or other symptoms associated with malignant ascites. •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 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/K212675
Methodology: https://510kreport.com/methodology