đź“‹ FDA Reference
5008x Hemodialysis System
Fresenius Medical Care
Summary: The 5008x hemodialysis system is a medical device used for dialysis treatment in patients with kidney failure. It is typically operated by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K231534 ↗
Decision Date ?
February 2, 2024
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The 5008x hemodialysis system by Fresenius Medical Care was cleared through the FDA 510k pathway on February 2, 2024. It is a Class 2 device under product code KDI.
What It Is
The 5008x hemodialysis system is an advanced dialysis machine designed to filter and purify the blood of patients with end-stage renal disease. It works by removing waste products and excess fluid from the blood, mimicking the function of healthy kidneys. The system is equipped with features to enhance patient safety and treatment efficiency, including automatic monitoring and adjustment capabilities.
FDA-Cleared Indications
- Hemodialysis treatment for patients who require removal of waste products and excess fluid from the blood because of kidney failure.
- Use with compatible dialyzers and bloodline systems as part of a prescribed hemodialysis treatment.
Clinical Applications
- Maintenance hemodialysis for patients with end-stage kidney disease.
- Hemodialysis for patients with chronic kidney disease when renal replacement therapy is required.
- Hemodialysis for patients with acute kidney injury when dialysis is clinically indicated.
- Treatment in hospitals, outpatient dialysis centers, and other qualified clinical settings.
Practical Considerations
- The system must be used with compatible dialyzers, bloodlines, concentrates, and other disposables specified by the manufacturer and clinical protocol.
- Treatment requires vascular access, such as an arteriovenous fistula, arteriovenous graft, or central venous dialysis catheter.
- Trained dialysis professionals must program, monitor, and respond to alarms during treatment; settings are individualized by the nephrology team.
- This is not an MRI-compatible implant or portable MRI device. The machine should be managed according to facility MRI safety procedures and kept outside restricted MRI areas unless specifically cleared.
- Contraindications, warnings, fluid-removal targets, anticoagulation, and treatment duration depend on the patient's condition, vascular access, prescription, and the manufacturer's labeling.
Frequently Asked Questions
What is the 5008x hemodialysis system used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste products and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with kidney failure requiring dialysis to manage waste and fluid balance.
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.