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Aspira Peritoneal Drainage System

by Merit Medical Systems, Inc.

510(k) K212675

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

13 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Special NumberK212675 Date14 Dec 2021ClearedStatusActive

Recalls

13 recalls · 13 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-1915-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1911-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1912-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1920-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1913-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1918-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1916-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1909-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1914-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1917-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1910-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1919-2023 FDA Class II initiated 22 Apr 2023
    • Ongoing Z-1908-2023 FDA Class II initiated 22 Apr 2023

    There is a potential that valve assemblies will not open. preventing fluid from draining.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PNG
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aspira Peritoneal Drainage System is a tunneled, long-term drainage catheter designed for peritoneal cavity fluid management. It is classified as a drainage catheter for refractory ascites and is intended for indwelling use to relieve symptoms caused by malignant ascites or recurrent fluid accumulation. Constructed for sustained drainage, the system facilitates outpatient or home-based management of peritoneal fluid, reducing the need for repeated hospital interventions.

This device is supplied as a sterile, single-use system and is regulated under FDA 510(k) clearance (K212675). It is intended for peritoneal cavity drainage and is compatible with standard medical imaging protocols, though MRI safety specifics are not detailed in the regulatory data. The system includes multiple catheter sizes and variants, as referenced by the registration numbers (e.g., 3011642792, 3013557562). Storage and handling follow standard aseptic protocols for implanted medical devices, with no additional regulatory restrictions noted beyond its FDA clearance.

From the manufacturer

The Aspira Drainage System is a tunneled, long-term catheter used to drain accumulated fluid from the pleural or peritoneal cavity to relieve symptoms associated with recurrent pleural effusion or malignant ascites.

Source: merit.com

PDF Aspira® Peritoneal Drainage Catheter - cloud.. The Aspira® Peritoneal Drainage Catheter is a tunneled, long-term catheter used to drain accumulated fluid from the peritoneal cavity to relieve symptoms associated with malignant ascites. The catheter is implanted in the patient's peritoneal cavity enabling the patient to perform intermittent malignant ascites drainage at home.

Source: cloud.merit.com

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Aspira Peritoneal Drainage System used for?

    The Aspira Peritoneal Drainage System is designed for managing fluid accumulation in the peritoneal cavity, specifically for patients with refractory ascites—such as malignant ascites or recurrent fluid buildup. It provides sustained drainage to relieve symptoms, enabling outpatient or home-based care and reducing the need for repeated hospital interventions.

  • Is the Aspira Peritoneal Drainage System single-use or reusable?

    The Aspira Peritoneal Drainage System is supplied as a sterile, single-use device. This ensures patient safety by minimizing the risk of contamination and infection, which is critical for indwelling medical devices like catheters.

  • What sizes or models are available for the Aspira Peritoneal Drainage System?

    The system includes multiple catheter sizes and variants, each identified by unique registration numbers. These include models like 3011642792, 3013557562, and others, allowing clinicians to select the appropriate size for their patient’s specific needs in peritoneal fluid management.

  • How should the Aspira Peritoneal Drainage System be stored?

    The Aspira Peritoneal Drainage System must be stored following standard aseptic protocols for implanted medical devices. Since it is sterile upon packaging, it should remain unopened until use and protected from contamination to maintain its integrity and safety for indwelling placement.

  • What regulatory clearance does the Aspira Peritoneal Drainage System have?

    The Aspira Peritoneal Drainage System is regulated under FDA 510(k) clearance with the reference number K212675. This clearance confirms that the device meets FDA standards for safety and effectiveness as a drainage catheter for refractory ascites.