Optiflux 200A

• • Terminated Z-1104-2014 FDA Class II ·initiated 4 Feb 2014

  Dialysate Port Leak During Priming of the Dialyzers

• • Terminated Z-1339-2012 FDA Not yet classified ·initiated 6 Mar 2012

  Risk of internal blood leaks affecting the hemodialyzers.

Full name

Fresenius Optiflux 200A

510(k) Number

K003498 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Optiflux 200A primarily used for in clinical settings?

  The Optiflux 200A is a high-permeability dialyzer specifically designed for hemodialysis treatment, which is a form of renal replacement therapy. It efficiently removes small and middle molecules from the blood, making it suitable for patients with end-stage renal disease requiring regular dialysis sessions. Its advanced polysulfone membrane ensures biocompatibility and consistent performance during these treatments.

• Is the Optiflux 200A intended for single-use or reusable applications?

  The Optiflux 200A is explicitly designed for single-use in hemodialysis settings. While it may be supplied as either a reusable or disposable component depending on the model variant, it must always be handled under sterile conditions to ensure patient safety and device efficacy.

• What storage and handling precautions should be taken with the Optiflux 200A?

  The Optiflux 200A must be stored and handled according to the manufacturer’s guidelines to maintain its sterility and functionality. Since it is intended for single-use, it should be kept in a sealed, sterile packaging until use. Improper storage could compromise its performance or risk contamination, so adherence to Fresenius Medical Care’s instructions is critical.

• What regulatory pathway does the Optiflux 200A follow, and what does that mean for its use?

  The Optiflux 200A received FDA 510(k) clearance (K003498) under the product code KDI, which categorizes it as a dialyzer for hemodialysis. The clearance was granted under 21 CFR 876.5860 and includes a special review designation for applications in gastroenterology and urology—though this does not alter its primary use in renal replacement therapy. Clinicians should confirm its intended use aligns with FDA-cleared indications for hemodialysis.