Fresenius Liberty Cycler

• • Terminated Z-2085-2021 FDA Class II ·initiated 28 Apr 2021

  Exposed to freezing temperatures due to refrigerated truck malfunctions

• • Terminated Z-0693-2016 FDA Class II ·initiated 15 Dec 2015

  The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

• • Terminated Z-0148-2014 FDA Class II ·initiated 14 Oct 2013

  Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

• • Terminated Z-1674-2013 FDA Class II ·initiated 3 Jun 2013

  Cassette may leak during set up or during peritoneal dialysis treatment

• • Terminated Z-0799-2013 FDA Class II ·initiated 12 Oct 2012

  There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

• • Terminated Z-1448-2012 FDA Not yet classified ·initiated 30 Mar 2012

  Increased risk of intraperitoneal volume (IIPV), referred to as Overfill

• 3 recalls, same reason

  • Terminated Z-0103-2011 FDA Unclassified (pre-2012) ·initiated 3 Sep 2010
  • Terminated Z-0104-2011 FDA Unclassified (pre-2012) ·initiated 3 Sep 2010
  • Terminated Z-0105-2011 FDA Unclassified (pre-2012) ·initiated 3 Sep 2010

  Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.

510(k) Number

K043363 ↗

FDA Product Code

FKX

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Fresenius Medical Care North America →

• What types of patients can use the Fresenius Liberty Cycler, and how does it support their treatment?

  The Fresenius Liberty Cycler is designed for patients requiring peritoneal dialysis, a process that filters waste and excess fluids from the blood using the peritoneal membrane in the abdomen. It automates the exchange of dialysate fluid during both acute (short-term) and chronic (long-term) care, making it suitable for hospital and dialysis center settings. The device controls infusion, dwell (fluid resting in the peritoneal cavity), and drainage phases programmatically, ensuring precise and consistent therapy delivery.

• Is the Liberty Cycler a single-use or reusable device, and what does that mean for maintenance?

  The Liberty Cycler is a reusable medical system, meaning it is built to be used repeatedly across multiple patients after proper cleaning, disinfection, and maintenance. However, it requires the use of disposable components as needed for each procedure to maintain sterile conditions during use. This design balances durability with hygiene, allowing facilities to rely on the same machine while ensuring patient safety.

• What regulatory pathway does the Liberty Cycler follow, and how does that affect its use in clinical settings?

  The Fresenius Liberty Cycler is regulated under the FDA’s 510(k) clearance pathway (K043363), meaning it has been deemed *substantially equivalent* to a legally marketed device already on the market. This clearance confirms its compliance with FDA standards outlined in 21 CFR 876.5630, ensuring it meets safety and performance requirements for use in clinical settings like hospitals and dialysis centers. Clinicians can rely on its regulatory approval when integrating it into peritoneal dialysis protocols.

• Are there multiple models or configurations of the Liberty Cycler, and how do they differ for patient care?

  Yes, the Liberty Cycler comes in multiple model and reference codes (e.g., 3030306055, 1721676), each tailored to accommodate different patient needs or procedural requirements. These variations may reflect differences in software programming, connectivity options, or compatibility with specific disposable components. The diversity allows facilities to select configurations that align with their workflows or patient populations, ensuring flexibility in automated peritoneal dialysis delivery.

• How is sterility maintained during use of the Liberty Cycler, and what disposable components are involved?

  The Liberty Cycler operates under sterile conditions during use, relying on disposable components—such as tubing sets, connectors, and possibly bags—to maintain asepsis. While the machine itself is reusable and cleaned between uses, the single-use disposables ensure that each patient’s treatment begins with a sterile setup, reducing contamination risks. This design aligns with peritoneal dialysis protocols, where sterility is critical to preventing infections.