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Fresenius 2008t Hemodialysis Machine
Fresenius Medical Care North America, Design Cente
Summary: The Fresenius 2008T Hemodialysis Machine is a medical device used for hemodialysis in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K120505 ↗
Decision Date ?
March 6, 2012
Product Code ?
KDI
Device Class ?
Class 2
Evidence ?
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared through the FDA 510(k) pathway on March 6, 2012. It is manufactured by Fresenius Medical Care North America and is classified as a Class 2 device.
What It Is
The Fresenius 2008T Hemodialysis Machine is a sophisticated device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are not functioning properly. It operates by circulating the patient’s blood through a dialyzer, where it is cleaned and then returned to the body. This machine is equipped with advanced features to ensure patient safety and treatment efficacy, including real-time monitoring of treatment parameters.
FDA-Cleared Indications
- Use for hemodialysis treatment in patients with renal failure who require removal of metabolic waste products and excess fluid from the blood.
- Use with compatible dialyzers, bloodlines, and associated dialysis supplies according to the device labeling and treatment prescription.
Clinical Applications
- Hemodialysis for patients with end-stage renal disease who require ongoing renal replacement therapy.
- Hemodialysis for patients with acute kidney injury when temporary renal replacement therapy is needed.
- Treatment in outpatient dialysis centers, hospitals, and other appropriately equipped healthcare settings.
- Delivery and monitoring of prescribed blood-flow, dialysate-flow, ultrafiltration, and treatment-duration settings during dialysis.
Practical Considerations
- The machine is operated by trained dialysis professionals and must be used with compatible dialyzers, bloodlines, concentrates, water systems, and accessories.
- Treatment requires vascular access, usually an arteriovenous fistula, arteriovenous graft, or dialysis catheter; the access is connected to the extracorporeal blood circuit.
- It is not an MRI-compatible device for use in the MRI scanner room unless the specific installation and model have been evaluated and labeled for that environment. Keep the machine and associated equipment outside restricted MRI zones unless facility guidance permits otherwise.
- Appropriate water treatment, electrical power, disinfection, preventive maintenance, calibration, alarm testing, and infection-control procedures are required.
- The machine does not determine whether dialysis is appropriate for an individual patient. Nephrology clinicians prescribe treatment and assess contraindications, vascular access, hemodynamic stability, and fluid-removal goals.
Related Literature
The linked study investigated the use of the Seraph-100 Hemoperfusion device in critically ill COVID-19 patients. Four patients with severe respiratory failure were treated with the Seraph-100, which is used in conjunction with a conventional dialysis machine like the Fresenius 2008T. The study reported improvements in respiratory parameters, but the small sample size and lack of a control group limit the generalizability of the findings.
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 products and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for patients with end-stage renal disease or acute kidney failure 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.