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hemodialysis concentrates and related products
Breem Laboratories
Summary: Hemodialysis concentrates by Breem Laboratories are used in dialysis treatment to manage waste removal in patients with renal failure. Key evidence highlights their role in improving quality of life and managing healthcare costs.
FDA Clearance Information
Pathway
510K
Number
K860336 ↗
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. Manufactured by Breem Laboratories, it is classified as a Class 2 medical device.
What It Is
Hemodialysis concentrates are solutions used in dialysis machines to help remove waste products from the blood of patients with renal failure. They are essential in maintaining electrolyte balance and removing toxins during hemodialysis.
Clinical Applications
Commonly used in patients with end-stage renal disease (ESRD) undergoing hemodialysis. These concentrates are crucial in managing chronic kidney disease and improving patient outcomes in dialysis centers.
Evidence Summary
The literature includes 10 studies, ranging from 2013 to 2025, covering various aspects of dialysis treatment. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report improvements in health-related quality of life and reductions in healthcare costs associated with hemodialysis. The concentrates are effective in maintaining electrolyte balance and supporting overall dialysis efficiency.
Safety Profile
Reported complications include potential peritoneal fibrosis in long-term dialysis and challenges in maintaining optimal dialysis efficiency. Safety profiles are generally favorable with appropriate use.
Evidence Limitations
Evidence gaps include limited long-term safety data and variability in study designs. Further research is needed to explore the long-term effects of hemodialysis concentrates on patient outcomes.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrates?
Indicated for use in patients with end-stage renal disease requiring hemodialysis to manage waste removal and electrolyte balance.
What outcomes have been reported in clinical studies?
Studies report improved quality of life and reduced healthcare costs for patients undergoing hemodialysis.
What complications have been reported?
Safety data indicate potential for peritoneal fibrosis and challenges in maintaining dialysis efficiency over time.
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.