Optiflux 200NR

• 3 recalls, same reason

  • Terminated Z-1099-2014 FDA Class II ·initiated 4 Feb 2014
  • Terminated Z-1101-2014 FDA Class II ·initiated 4 Feb 2014
  • Terminated Z-1103-2014 FDA Class II ·initiated 4 Feb 2014

  Dialysate Port Leak During Priming of the Dialyzers

• • Terminated Z-1951-2010 FDA Unclassified (pre-2012) ·initiated 14 May 2010

  Hemodialyzer may leak at the header/end cap

• • Terminated Z-0738-2008 FDA Unclassified (pre-2012) ·initiated 3 Dec 2007

  Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.

• • Terminated Z-0333-06 FDA Unclassified (pre-2012) ·initiated 28 Nov 2005

  Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR

Full name

Fresenius Optiflux 200NR

510(k) Number

K002277 ↗

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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  Class II

  FDA 510(k) K070177 Active Cleared 29 Mar 2007

• Crit-Line Clip (Clic) Blood Chamber

  Class II

  FDA 510(k) K152953 Active Cleared 5 Nov 2015

• Optiflux dialyzer Open recall

  Class II

  FDA 510(k) K162488 Active Cleared 6 Apr 2017

• Fresenius Art Hemoadsorption System

  Unclassified

  FDA 510(k) K050273 Active Cleared 8 Jun 2005

• Frsenius Pd Iqcard Cycler

  Class II

  FDA 510(k) K002892 Active Cleared 5 Apr 2001

• Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination

  Class II

  FDA 510(k) K991520 Active Cleared 30 Jul 1999

See all devices from Fresenius Medical Care North America →

• What is the Optiflux 200NR dialyzer used for?

  The Optiflux 200NR is a high-permeability dialyzer designed specifically for hemodialysis treatment. It removes waste products, excess fluids, and electrolytes from the blood of patients with end-stage renal disease (ESRD). This process is critical for maintaining electrolyte balance and fluid homeostasis in patients undergoing renal replacement therapy.

• Is the Optiflux 200NR dialyzer single-use or reusable?

  The Optiflux 200NR dialyzer is supplied as a single-use device. This design ensures patient safety by eliminating the risk of cross-contamination between uses, which is particularly important in sterile medical procedures like hemodialysis. Single-use devices also reduce the need for reprocessing and maintenance.

• How should the Optiflux 200NR dialyzer be stored?

  The Optiflux 200NR dialyzer should be stored according to standard sterile handling protocols for single-use medical devices. It is supplied sterile, so it must remain unopened and protected from contamination until use. Storage should follow manufacturer guidelines to preserve sterility and functionality, typically in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory approval does the Optiflux 200NR dialyzer have?

  The Optiflux 200NR dialyzer is authorized under FDA 510(k) clearance with the clearance number K002277. This indicates that the device has been deemed substantially equivalent to a legally marketed predicate device by the FDA, ensuring it meets applicable safety and performance standards for its intended use in hemodialysis.

• In which clinical settings is the Optiflux 200NR dialyzer primarily used?

  The Optiflux 200NR dialyzer is primarily intended for use in clinical settings such as dialysis centers, where hemodialysis is performed. While it is classified under both gastroenterology and urology in administrative records, its primary and distinct function remains within renal dialysis procedures for patients with end-stage renal disease.