2008K@Home Hemodialysis Machine

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K124035 ↗

FDA Product Code

ONW

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Fresenius Medical Care North America →

• What is the 2008K@Home Hemodialysis Machine used for?

  The 2008K@Home Hemodialysis Machine is designed for extracorporeal blood purification, specifically for patients with end-stage renal disease. It mimics the function of healthy kidneys by filtering blood through a semipermeable membrane to remove waste products, excess fluids, and electrolytes. This allows patients to undergo hemodialysis treatments in a home setting, rather than a clinical environment, supporting chronic renal replacement therapy.

• Is the 2008K@Home Hemodialysis Machine single-use or reusable?

  The 2008K@Home Hemodialysis Machine is a reusable medical system. Between treatments, it requires thorough cleaning, disinfection, and maintenance to ensure sterility and proper functionality. This process is critical for patient safety and device performance, as outlined by the manufacturer’s guidelines.

• What safety considerations apply to the 2008K@Home Hemodialysis Machine?

  The machine is not MRI-compatible, meaning it should never be placed in an MRI environment. Additionally, it must be used in settings that comply with hemodialysis safety protocols to minimize risks. Proper storage and handling, as specified by the manufacturer, are essential to maintain performance and ensure patient safety.

• How is the 2008K@Home Hemodialysis Machine regulated?

  The 2008K@Home Hemodialysis Machine holds FDA clearance under the 510(k) pathway (K124035), confirming it meets regulatory standards for Class II medical devices. Its classification as a Hemodialysis System for Home Use ensures it adheres to strict safety and performance requirements for chronic renal replacement therapy.

• What maintenance steps are required between patient treatments?

  Between treatments, the machine must undergo cleaning, disinfection, and maintenance procedures as directed by the manufacturer. These steps are mandatory to preserve sterility, functionality, and patient safety. Failure to follow these protocols could compromise device performance or introduce contamination risks.