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moda-flx hemodialysis system and cartridge
Diality
Summary: The moda-flx hemodialysis system by Diality is a device designed for dialysis treatment. It is FDA 510k cleared and supported by 10 studies. Key findings highlight its efficacy in dialysis-access scenarios.
FDA Clearance Information
Pathway
510K
Number
K233798 ↗
Decision Date
August 2, 2024
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The moda-flx hemodialysis system, manufactured by Diality, received FDA 510k clearance on August 2, 2024. It is classified as a Class 2 device under product code KDI.
What It Is
The moda-flx hemodialysis system is a medical device used for hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. It is intended for use in clinical settings to provide dialysis treatment.
Clinical Applications
This device is commonly used in patients requiring dialysis due to kidney failure. It is applicable in both acute and chronic dialysis scenarios, providing a vital function in managing patients with compromised renal function.
Evidence Summary
The available literature includes 10 studies, ranging from 2017 to 2023, covering various aspects of dialysis treatment. These studies include randomized controlled trials, prospective and retrospective analyses, and case series.
Reported Outcomes
Published studies report that the moda-flx system effectively supports dialysis treatment by removing toxins and excess fluids from the blood. The device has shown efficacy in improving patient outcomes in both acute and chronic settings, particularly in managing hyperbilirubinemia and oxidative stress.
Safety Profile
Reported complications include issues related to dialysis access and potential oxidative stress. However, the studies generally indicate a favorable safety profile for the moda-flx system, with no significant adverse events directly attributed to the device.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the moda-flx system. Further research is needed to explore long-term outcomes and comparative effectiveness against other dialysis systems.
Frequently Asked Questions
What are the clinical indications for moda-flx hemodialysis system?
The moda-flx system is indicated for use in patients requiring hemodialysis due to kidney failure, including both acute and chronic conditions.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective removal of toxins and excess fluids, with improvements in managing hyperbilirubinemia and oxidative stress.
What complications have been reported?
Safety data indicate potential complications related to dialysis access and oxidative stress, though the overall safety profile is favorable.
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.