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hemodialysis concentrates
Dove Medical Supplies
Summary: Hemodialysis concentrates are used in dialysis to maintain electrolyte balance and remove waste products from the blood. Key evidence highlights their efficacy in maintaining dialysis water quality and minimizing side effects.
FDA Clearance Information
Pathway
510K
Number
K883068 ↗
Decision Date
December 22, 1988
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemodialysis concentrates by Dove Medical Supplies were cleared via the FDA 510(k) pathway on December 22, 1988. They are classified as Class 2 devices under product code KPO.
What It Is
Hemodialysis concentrates are solutions used in dialysis machines to help remove waste products and excess electrolytes from the blood. They are essential in maintaining the chemical balance during hemodialysis treatment.
Clinical Applications
These concentrates are commonly used in patients with chronic kidney disease requiring hemodialysis. They are crucial in settings where precise electrolyte management is needed to prevent complications associated with renal failure.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to retrospective analyses, published between 1973 and 2016. These studies focus on the efficacy and safety of hemodialysis concentrates.
Reported Outcomes
Published studies report that hemodialysis concentrates effectively maintain dialysis water quality and reduce microbial contamination. They also highlight the potential for minimizing side effects associated with acetate intolerance by using alternative buffering agents.
Safety Profile
Reported complications include potential microbial contamination if water quality is not adequately controlled. Some studies also mention the risk of hyperacetatemia in patients sensitive to acetate.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to explore long-term outcomes and the impact of different buffering agents in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrates?
Hemodialysis concentrates are indicated for use in patients undergoing hemodialysis to manage electrolyte balance and remove waste products from the blood.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of dialysis water quality and reduced side effects with alternative buffering agents.
What complications have been reported?
Safety data indicate potential microbial contamination and hyperacetatemia in acetate-sensitive patients.
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.