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high flux hemodialysis membrane dialyzer or high flux hollow fiber dialyzer models aps-r -m -s -e and -ex
Asahi Medical
Summary: The high flux hemodialysis membrane dialyzer by Asahi Medical is used in dialysis to remove toxins from the blood. Key evidence suggests improved removal of large-molecule toxins and potential prognostic benefits.
FDA Clearance Information
Pathway 510K
Number K041726 ↗
Decision Date July 23, 2004
Product Code KDI
Device Class Class 2
Evidence 0 studies
The device was cleared by the FDA through the 510(k) pathway on July 23, 2004. It is manufactured by Asahi Medical and classified as a Class 2 device.
What It Is
The high flux hemodialysis membrane dialyzer is a medical device designed to filter blood during dialysis, using a high flux membrane to remove toxins and waste products. It is intended for patients requiring hemodialysis.
Clinical Applications
This device is commonly used in clinical settings for patients undergoing hemodialysis, particularly those who require efficient removal of large-molecule toxins. It is suitable for chronic kidney disease patients on dialysis.
Evidence Summary
The literature includes 15 studies, ranging from randomized controlled trials to observational studies, published between 2022 and 2025. These studies explore the efficacy and safety of high flux membranes in dialysis.
Reported Outcomes
Published studies report that high flux membranes improve the removal of large-molecule toxins, such as α1-microglobulin. Some studies suggest potential prognostic benefits, including improved patient outcomes with S-type membranes.
Safety Profile
Reported complications include impaired platelet aggregation in a significant proportion of patients undergoing hemodialysis with high flux membranes. No other major adverse events were highlighted in the studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to confirm long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for high flux hemodialysis membrane dialyzer?
The device is indicated for use in patients requiring hemodialysis, particularly for the removal of large-molecule toxins.
What outcomes have been reported in clinical studies?
Studies report improved removal of large-molecule toxins and potential prognostic benefits with certain membrane types.
What complications have been reported?
Safety data indicate impaired platelet aggregation in some patients using high flux membranes.
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.