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Fresenius 2008t Hemodialysis Machine Model 190573
Fresenius Medical Care North America, Design Cente
Summary: The Fresenius 2008T Hemodialysis Machine is used for renal replacement therapy in patients with end-stage renal disease. It is primarily operated by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101715 ↗
Decision Date ?
December 21, 2010
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared through the FDA 510(k) pathway on December 21, 2010. It is manufactured by Fresenius Medical Care North America and is classified as a Class 2 device under product code KDI.
What It Is
The Fresenius 2008T Hemodialysis Machine is a medical device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are no longer able to function effectively. The machine uses a dialyzer, often referred to as an artificial kidney, to clean the blood. It is equipped with advanced features for monitoring and adjusting treatment parameters to ensure patient safety and treatment efficacy.
FDA-Cleared Indications
- For hemodialysis treatment of patients with renal failure who require renal replacement therapy.
- For use with compatible dialyzers, bloodlines, dialysate, and related extracorporeal blood-processing components according to the device labeling.
- For operation by trained healthcare professionals in appropriate clinical dialysis environments.
Clinical Applications
- Hemodialysis for patients with end-stage renal disease or other renal failure requiring renal replacement therapy.
- Removal of metabolic waste products and excess fluid from the blood through an extracorporeal dialysis circuit.
- Management of fluid and electrolyte balance during prescribed hemodialysis treatments.
- Use in hospital-based and outpatient dialysis settings when operated and maintained according to the manufacturer’s instructions.
Practical Considerations
- The machine requires a compatible dialyzer, bloodline set, dialysate supplies, vascular access, and trained clinical staff.
- Vascular access may include an arteriovenous fistula, arteriovenous graft, or dialysis catheter; the access itself is not part of the machine.
- Treatment parameters, alarms, disinfection, preventive maintenance, calibration, and troubleshooting must follow the manufacturer’s instructions and facility protocols.
- This is not an MRI device and should not be placed in the MRI scanner room unless the manufacturer and facility have specifically established compatible conditions.
- Contraindications, warnings, and component compatibility should be reviewed in the current FDA-cleared labeling and operator manual before treatment.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with end-stage renal disease to filter waste and excess fluids from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with end-stage renal disease who require hemodialysis.
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.