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2008k2 hemodialysis machine
Fresenius Medical Care Renal Therapies Group
Summary: The 2008k2 is a hemodialysis machine by Fresenius Medical Care, primarily used for renal replacement therapy. Key evidence highlights its role in fluid volume management during dialysis.
FDA Clearance Information
Pathway
510K
Number
K153449 ↗
Decision Date
April 26, 2016
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The 2008k2 hemodialysis machine was cleared through the FDA 510k pathway on April 26, 2016. It is manufactured by Fresenius Medical Care and classified as a Class 2 device.
What It Is
The 2008k2 is a hemodialysis machine designed to provide renal replacement therapy by removing waste products and excess fluid from the blood. It is intended for use in clinical settings to support patients with renal failure.
Clinical Applications
Commonly used in hospital and dialysis center settings, the 2008k2 is employed for patients requiring regular hemodialysis due to chronic kidney disease or acute renal failure. It is integral in managing fluid balance and waste removal.
Evidence Summary
The available literature includes 10 studies, with types ranging from RCTs to case series, published between 2021 and 2023. These studies explore various aspects of hemodialysis, including fluid management and home dialysis therapies.
Reported Outcomes
Published studies report that the 2008k2 hemodialysis machine is effective in managing fluid volume during dialysis sessions. It supports the probing-dry-weight concept and has been associated with improved mortality outcomes in historical contexts.
Safety Profile
Reported complications include challenges in accurately determining fluid removal during dialysis sessions. No specific adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific data on long-term outcomes and direct comparisons with other hemodialysis machines. Further research is needed to explore the machine's efficacy in diverse patient populations and settings.
Frequently Asked Questions
What are the clinical indications for 2008k2 hemodialysis machine?
The 2008k2 is indicated for use in patients requiring hemodialysis due to chronic kidney disease or acute renal failure.
What outcomes have been reported in clinical studies?
Studies report effective fluid volume management and historical improvements in mortality outcomes with the use of the 2008k2.
What complications have been reported?
Safety data indicate challenges in fluid removal accuracy, but no specific adverse events are detailed in the evidence.
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.