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dialysate concentrate for hemodialysis
Cobe Laboratories
Summary: Dialysate concentrate for hemodialysis is used to manage electrolyte balance during dialysis. Key evidence highlights its role in managing serum potassium and sodium levels.
FDA Clearance Information
Pathway
510K
Number
K810280 ↗
Decision Date
February 19, 1981
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The dialysate concentrate for hemodialysis by Cobe Laboratories was cleared via the FDA 510k pathway on February 19, 1981. It is classified as a Class 2 device.
What It Is
The dialysate concentrate is a solution used in hemodialysis to help maintain electrolyte balance by removing waste products and excess substances from the blood. It is intended for use in patients undergoing hemodialysis treatment.
Clinical Applications
This device is commonly used in clinical settings for patients with chronic kidney disease requiring hemodialysis. It helps manage electrolyte levels, particularly potassium and sodium, during the dialysis process.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and prospective studies, published between 2023 and 2025. These studies explore the effects of dialysate composition on patient outcomes.
Reported Outcomes
Published studies report that adjusting dialysate potassium and sodium concentrations can influence patient outcomes, including managing hyperkalemia and hypertension. Evidence suggests that individualized dialysate prescriptions may optimize treatment efficacy.
Safety Profile
Reported complications include potential imbalances in electrolyte levels, which require careful monitoring. Some studies highlight the need for precise adjustment of dialysate components to avoid adverse effects.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish standardized guidelines for dialysate composition and its impact on long-term patient outcomes.
Frequently Asked Questions
What are the clinical indications for dialysate concentrate for hemodialysis?
The device is indicated for use in managing electrolyte balance during hemodialysis in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies report that dialysate composition affects serum potassium and sodium levels, influencing outcomes like hyperkalemia management and blood pressure control.
What complications have been reported?
Safety data indicate potential electrolyte imbalances, necessitating careful monitoring and individualized dialysate prescriptions.
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.