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hemodialysis concentrate formulations additives
Renal Hygienics
Summary: Hemodialysis concentrate formulations additives by Renal Hygienics are used in dialysis treatments. Key evidence highlights the stability of iPTH levels and prevention of hypomagnesemia with magnesium supplementation.
FDA Clearance Information
Pathway
510K
Number
K860297 ↗
Decision Date
March 4, 1986
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 4, 1986, by Renal Hygienics. It is classified as a Class 2 device under product code FKQ.
What It Is
Hemodialysis concentrate formulations additives are used to prepare dialysate solutions for hemodialysis, a treatment for renal failure. They are designed to optimize the chemical composition of the dialysate to improve patient outcomes.
Clinical Applications
These additives are commonly used in clinical settings for patients undergoing hemodialysis, particularly those with chronic kidney disease. They help in maintaining electrolyte balance and preventing complications during dialysis.
Evidence Summary
The literature includes 10 studies, comprising prospective and retrospective designs, published between 2021 and 2025. These studies explore the efficacy and safety of different dialysate formulations.
Reported Outcomes
Published studies report that citrate dialysates with magnesium supplementation stabilize iPTH levels and prevent hypomagnesemia. Additionally, post-dialysis total calcium levels are reduced with citrate dialysates compared to acetate.
Safety Profile
Reported complications include no significant increase in adverse events when using citrate dialysates with magnesium supplementation. Safety profiles are generally favorable.
Evidence Limitations
Current evidence is limited by the small number of studies directly addressing the specific formulations. Further research is needed to explore long-term outcomes and broader patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrate formulations additives?
These additives are indicated for use in hemodialysis to optimize dialysate composition and improve treatment outcomes.
What outcomes have been reported in clinical studies?
Studies report stable iPTH levels and prevention of hypomagnesemia with magnesium-supplemented citrate dialysates.
What complications have been reported?
Safety data indicate no significant increase in adverse events with the use of citrate dialysates with magnesium supplementation.
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.