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western dialysis hemodialysis concentrate
Western Dialysis Supplies
Summary: Western Dialysis Hemodialysis Concentrate is a medical device used in hemodialysis to maintain electrolyte balance in patients with kidney failure. Key evidence highlights its role in preventing catheter dysfunction and managing trace element levels.
FDA Clearance Information
Pathway
510K
Number
K941958 ↗
Decision Date
September 30, 1994
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The Western Dialysis Hemodialysis Concentrate was cleared by the FDA via the 510(k) pathway on September 30, 1994. It is manufactured by Western Dialysis Supplies and classified as a Class 2 device.
What It Is
The Western Dialysis Hemodialysis Concentrate is a solution used in hemodialysis to help maintain the necessary electrolyte balance in patients undergoing treatment for kidney failure. It is designed to work with dialysis machines to facilitate the removal of waste products from the blood.
Clinical Applications
This device is commonly used in clinical settings for patients with end-stage renal disease requiring hemodialysis. It is essential in maintaining electrolyte homeostasis and preventing complications associated with dialysis treatment.
Evidence Summary
The available literature includes 8 studies, comprising randomized controlled trials and observational studies, published between 2020 and 2025. These studies explore various aspects of dialysis treatment, including catheter dysfunction and trace element management.
Reported Outcomes
Published studies report that the use of hemodialysis concentrates is associated with improved management of electrolyte levels and prevention of catheter dysfunction. Additionally, the concentrate plays a role in managing trace element accumulation in dialysis patients.
Safety Profile
Reported complications include potential trace element imbalances, such as chromium accumulation, which may affect patient outcomes. The studies emphasize the importance of monitoring trace element levels during treatment.
Evidence Limitations
The evidence is limited by the variability in study designs and the focus on specific outcomes like catheter dysfunction and trace element management. Further research is needed to explore long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Western Dialysis Hemodialysis Concentrate?
The concentrate is indicated for use in hemodialysis to maintain electrolyte balance and prevent complications in patients with kidney failure.
What outcomes have been reported in clinical studies?
Studies report improved management of electrolyte levels and prevention of catheter dysfunction, with a focus on trace element management.
What complications have been reported?
Safety data indicate potential trace element imbalances, such as chromium accumulation, necessitating careful monitoring during treatment.
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.