Aquadex FlexFlow System 2.0

• • Completed Z-0831-2025 FDA Class I ·initiated 11 Dec 2024

  The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

510(k) Number

K192756 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Aquadex System 100, Model A1100

  Class II

  FDA 510(k) K040489 Active Cleared 27 Apr 2004

• System 100; S-100 Ultrafiltration Console; Bdt 500 Ultrafiltration Set

  Class II

  FDA 510(k) K013733 Active Cleared 3 Jun 2002

• Aquadex Flexflow System

  Class II

  FDA 510(k) K071854 Active Cleared 7 Sep 2007

• Aquadex System

  Class II

  FDA 510(k) K050609 Active Cleared 9 Nov 2005

• Modification to Aquadex Flexflow System

  Class II

  FDA 510(k) K062922 Active Cleared 13 Dec 2006

• 5.2F Dual Lumen Extended Length Catheter (DELC)

  Class II

  FDA 510(k) K041791 Active Cleared 10 Sep 2004

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• What is the Aquadex FlexFlow System 2.0 used for?

  The Aquadex FlexFlow System 2.0 is designed for continuous ultrafiltration therapy, specifically to remove excess fluid and solutes from the bloodstream. It is intended for hospitalized patients weighing 20 kilograms or more who require controlled ultrafiltration due to fluid overload or other conditions necessitating temporary (up to 8 hours) or extended (longer than 8 hours) ultrafiltration support.

• Is the Aquadex FlexFlow System 2.0 single-use or reusable?

  The Aquadex FlexFlow System 2.0 is supplied as a single-use, sterile device. This design ensures patient safety by preventing cross-contamination and maintaining sterility between uses, which is critical in clinical settings where ultrafiltration therapy is administered.

• What are the key specifications or classifications for this device?

  The Aquadex FlexFlow System 2.0 is classified under 21 CFR 876.5860 as a Class II medical device with the product code KDI. It is intended for use in clinical settings where hemodialysis protocols are followed, ensuring compatibility with standard ultrafiltration therapy practices. The system’s high-permeability design supports efficient fluid management.

• How should the Aquadex FlexFlow System 2.0 be stored?

  While the provided data does not specify storage conditions explicitly, single-use sterile medical devices like the Aquadex FlexFlow System 2.0 are generally stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Always follow the manufacturer’s instructions for optimal shelf life and sterility preservation.

• What regulatory pathway was followed for this device?

  The Aquadex FlexFlow System 2.0 underwent a traditional 510(k) clearance process through the FDA, with a decision described as ‘Substantially Equivalent.’ The device was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, and it was determined to be substantially equivalent to a predicate device, ensuring compliance with regulatory standards for hemodialysis systems.