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fresenius 2008k home hemodialysis machine with wireless wetness detector wetalert
Fresenius Medical Care North America, Design Cente
Summary: The Fresenius 2008K home hemodialysis machine is designed for home use, providing flexibility in dialysis treatment. Key evidence shows its efficacy in home settings with comparable outcomes to in-center dialysis.
FDA Clearance Information
Pathway
510K
Number
K121421 ↗
Decision Date
January 17, 2013
Product Code
ONW
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008K home hemodialysis machine was cleared by the FDA via the 510(k) pathway on January 17, 2013. It is manufactured by Fresenius Medical Care North America and is classified as a Class 2 device.
What It Is
The Fresenius 2008K home hemodialysis machine is a medical device designed for home use, allowing patients to perform hemodialysis outside of clinical settings. It includes a wireless wetness detector, WetAlert, to enhance safety during treatment.
Clinical Applications
This device is commonly used in home hemodialysis settings for patients with end-stage renal disease (ESRD) who require regular dialysis. It is suitable for both short daily and prolonged nocturnal dialysis sessions.
Evidence Summary
The available literature includes three studies published between 2004 and 2016, focusing on clinical parameters, safety, and efficacy of the Fresenius 2008K home hemodialysis machine. These studies provide insights into its use in home settings.
Reported Outcomes
Published studies report that the Fresenius 2008K home hemodialysis machine provides clinical outcomes comparable to in-center dialysis. Patients using this device at home showed similar dialysis adequacy and clinical parameters over a one-year period.
Safety Profile
Reported complications include issues related to device handling and setup, as well as potential wetness detection failures. However, no significant adverse events were highlighted in the provided 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 safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Fresenius 2008K home hemodialysis machine?
The device is indicated for home hemodialysis in patients with end-stage renal disease who require regular dialysis treatment.
What outcomes have been reported in clinical studies?
Studies report that the device provides clinical outcomes comparable to in-center dialysis, with similar dialysis adequacy and clinical parameters.
What complications have been reported?
Reported complications include device handling issues and potential wetness detection failures, but no significant adverse events were noted.
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.