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2008k hemodialysis machine 2008k home hemodialysis machine 2008t hemodialysis machine
Fresenius Medical Care Renal Therapies Group
Summary: The 2008k hemodialysis machine by Fresenius Medical Care is designed for both in-center and home use. It is primarily used for patients requiring regular dialysis. Key evidence highlights its efficacy and safety in home settings.
FDA Clearance Information
Pathway
510K
Number
K150708 ↗
Decision Date
December 10, 2015
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The 2008k hemodialysis machine was cleared by the FDA through the 510(k) pathway on December 10, 2015. It is manufactured by Fresenius Medical Care Renal Therapies Group and classified as a Class 2 device.
What It Is
The 2008k hemodialysis machine is a medical device used to perform hemodialysis, a process that filters waste and excess fluid from the blood. It is intended for use in both clinical and home settings, providing flexibility in dialysis treatment.
Clinical Applications
Commonly used in patients with end-stage renal disease requiring regular dialysis, the 2008k machine is suitable for both in-center and home hemodialysis. It supports various dialysis schedules, including short daily and prolonged nocturnal sessions.
Evidence Summary
The available literature includes three studies published between 2004 and 2016. These studies evaluate the clinical parameters, safety, and efficacy of the 2008k machine in home hemodialysis settings, with a focus on patient outcomes over time.
Reported Outcomes
Published studies report that the 2008k hemodialysis machine is effective in maintaining dialysis adequacy and patient safety in home settings. Clinical parameters such as blood urea nitrogen levels were consistently managed, indicating effective waste removal.
Safety Profile
Reported complications include typical dialysis-related issues such as vascular access problems and hypotension. However, no unique safety concerns specific to the 2008k machine were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes and retrospective nature of the studies. Further research is needed to explore long-term outcomes and compare the 2008k machine with other dialysis systems in larger, randomized trials.
Frequently Asked Questions
What are the clinical indications for 2008k hemodialysis machine?
The 2008k hemodialysis machine is indicated for patients with end-stage renal disease requiring regular dialysis, suitable for both in-center and home use.
What outcomes have been reported in clinical studies?
Studies report effective management of clinical parameters such as blood urea nitrogen levels, indicating successful dialysis treatment with the 2008k machine.
What complications have been reported?
Reported complications include common dialysis-related issues like vascular access problems and hypotension, with no unique safety concerns specific to the 2008k machine.
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.