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hemocare hemodialysis system
Deka Research And Development
Summary: The HemoCare Hemodialysis System, developed by Deka Research, is designed for hemodialysis treatment. It is FDA 510k cleared and primarily used for home nocturnal dialysis in patients with ESRD. Two studies provide evidence on its continuous use and application in home settings.
FDA Clearance Information
Pathway
510K
Number
K233557 ↗
Decision Date
July 12, 2024
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The HemoCare Hemodialysis System received FDA clearance through the 510k pathway on July 12, 2024. It is manufactured by Deka Research and Development and is classified as a Class 2 device under product code KDI.
What It Is
The HemoCare Hemodialysis System is a medical device designed to facilitate hemodialysis treatment, particularly in home settings. It is intended for patients with end-stage renal disease (ESRD) requiring regular dialysis sessions.
Clinical Applications
This device is commonly used in home-based dialysis scenarios, allowing patients with ESRD to undergo nocturnal dialysis. It provides an option for continuous dialysis treatment outside of traditional clinical settings.
Evidence Summary
The available literature includes two studies focusing on the HemoCare Hemodialysis System. These studies explore its use in continuous and home nocturnal dialysis settings, although specific sample sizes and publication years are not detailed.
Reported Outcomes
Published studies report that the HemoCare Hemodialysis System is effective for continuous use in home settings, particularly for nocturnal dialysis in patients with ESRD. However, detailed efficacy outcomes are not specified in the provided evidence.
Safety Profile
Reported complications include typical risks associated with home hemodialysis, but specific adverse events are not detailed in the provided studies. Further research is needed to comprehensively assess safety profiles.
Evidence Limitations
The evidence is limited by the lack of detailed study outcomes and safety data. Further research is necessary to establish comprehensive efficacy and safety profiles, as well as to explore long-term use implications.
Frequently Asked Questions
What are the clinical indications for HemoCare Hemodialysis System?
The device is indicated for use in patients with end-stage renal disease (ESRD) requiring hemodialysis, particularly in home settings.
What outcomes have been reported in clinical studies?
The studies report effective use for continuous and nocturnal home dialysis, though specific outcomes are not detailed.
What complications have been reported?
Reported complications include general risks associated with home hemodialysis, but specific adverse events are not detailed in the studies provided.
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.