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moda-flx hemodialysis system cartridge 102121-001
Diality
Summary: The moda-flx hemodialysis system cartridge by Diality is designed for dialysis treatment. It has been FDA-cleared and is supported by 10 studies, highlighting its efficacy in toxin removal and safety profile.
FDA Clearance Information
Pathway
510K
Number
K243607 ↗
Decision Date
December 20, 2024
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The moda-flx hemodialysis system cartridge, manufactured by Diality, received FDA clearance via the 510(k) pathway on December 20, 2024. It is classified as a Class 2 device.
What It Is
The moda-flx hemodialysis system cartridge is an extracorporeal device used in hemodialysis to remove toxins from the blood. It employs a sorbent-based mechanism to adsorb harmful substances, intended for patients requiring dialysis.
Clinical Applications
Commonly used in clinical settings for patients with chronic kidney disease undergoing dialysis. It is particularly useful in scenarios requiring efficient toxin removal, such as in patients with end-stage renal disease.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and other study types, published between 2021 and 2025. These studies explore the device's efficacy in toxin removal and its application in dialysis.
Reported Outcomes
Published studies report that the moda-flx cartridge effectively removes toxins such as iodinated contrast and bilirubin. It has shown promise in improving dialysis efficiency and patient outcomes in chronic kidney disease management.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. The device's use in clinical settings has not been associated with significant safety concerns.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to explore long-term outcomes and broader patient populations.
Frequently Asked Questions
What are the clinical indications for moda-flx hemodialysis system cartridge?
The moda-flx cartridge is indicated for use in hemodialysis to remove toxins from the blood in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies have reported effective toxin removal, including iodinated contrast and bilirubin, with improved dialysis efficiency.
What complications have been reported?
Safety data from evidence indicates minimal adverse events, with no significant complications reported in clinical studies.
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.