📋 FDA Reference
Modification to Fresenius 2008t Hemodialysis Machine Model 190573
Fresenius Medical Care North America
Summary: The Fresenius 2008T Hemodialysis Machine is used for hemodialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093902 ↗
Decision Date ?
May 27, 2010
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The Fresenius 2008T Hemodialysis Machine, manufactured by Fresenius Medical Care North America, received FDA clearance through the 510(k) pathway on May 27, 2010. It is classified as a Class 2 device under product code KDI.
What It Is
The Fresenius 2008T Hemodialysis Machine is a sophisticated medical device designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are no longer able to do so effectively. This machine is equipped with advanced features to ensure precise control of dialysis parameters, enhancing patient safety and treatment efficacy. It includes components for blood and dialysate flow management, ultrafiltration control, and patient monitoring.
FDA-Cleared Indications
- Hemodialysis treatment for patients with renal failure.
- Use in clinical settings under the direction of qualified healthcare professionals.
- Treatment using extracorporeal blood circulation, dialysate delivery, and controlled fluid removal.
Clinical Applications
- Maintenance hemodialysis for patients with end-stage kidney disease.
- Hemodialysis for selected patients with acute kidney injury when renal replacement therapy is required.
- Removal of metabolic waste and excess fluid during a prescribed dialysis treatment.
- Management of fluid, electrolyte, and acid-base abnormalities through hemodialysis.
Practical Considerations
- The machine requires compatible blood tubing, dialyzers, dialysate supplies, water treatment, and other dialysis consumables specified by the manufacturer and facility protocols.
- Treatment settings, including blood flow, dialysate flow, ultrafiltration, and treatment duration, must be prescribed and monitored by qualified dialysis personnel.
- Vascular access is required, typically an arteriovenous fistula, arteriovenous graft, or dialysis catheter.
- This is an external dialysis system, not an implanted device; MRI compatibility of the machine and its accessories is not applicable in the usual sense, and the machine should not be taken into the MRI scanner room unless specifically cleared for that environment.
- Routine disinfection, preventive maintenance, calibration, alarm testing, and water-quality monitoring are required for safe operation.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses in nephrology and renal care settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for hemodialysis treatment in patients with kidney failure, including those with chronic and acute conditions.
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.