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5008x hemodialysis system
Fresenius Medical Care Renal Therapies Group
Summary: The 5008x hemodialysis system is a medical device used for dialysis treatment in patients with renal failure. It is typically used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K243505 ↗
Decision Date
May 30, 2025
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The 5008x hemodialysis system, manufactured by Fresenius Medical Care Renal Therapies Group, was cleared via the FDA 510k pathway on May 30, 2025. It is classified as a Class 2 device under product code KDI.
What It Is
The 5008x hemodialysis system is an advanced dialysis machine designed to perform hemodialysis, a process that filters and purifies the blood using a dialyzer, or artificial kidney. It is used to treat patients with chronic or acute renal failure by removing waste products and excess fluid from the blood. The system is equipped with features to enhance patient safety and treatment efficacy, such as automated monitoring and control of dialysis parameters.
Clinical Applications
This device is commonly used in hospital dialysis units and outpatient dialysis centers. It is essential for the management of patients with end-stage renal disease (ESRD) who require regular dialysis sessions. Nephrologists and dialysis nurses use the 5008x system to provide life-sustaining treatment to patients, ensuring the removal of toxins and fluid balance. It is suitable for adult and pediatric patients, depending on the configuration and settings used.
Indications for Use
The 5008x hemodialysis system is indicated for patients with kidney failure who need dialysis to remove waste and excess fluid from their blood. It is suitable for both chronic dialysis patients and those with acute kidney injury requiring temporary dialysis support.
Practical Considerations
The 5008x system is compatible with standard dialysis consumables, including dialyzers and bloodlines. It offers customizable settings to accommodate patient-specific treatment needs. Clinicians should be familiar with the machine's interface and safety features to optimize treatment outcomes.
Frequently Asked Questions
What is 5008x hemodialysis system used for?
The 5008x hemodialysis system is used for performing hemodialysis in patients with renal failure to remove waste products and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in hospital and outpatient dialysis settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring dialysis due to kidney failure, including those with chronic kidney disease and acute kidney injury.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.