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renal systems hemodialysis concentrate
Renal Systems
Summary: Renal Systems Hemodialysis Concentrate is used in hemodialysis to create dialysis fluid. It is FDA-cleared and supported by 12 studies, highlighting its role in effective dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K792213 ↗
Decision Date
January 4, 1980
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA via the 510(k) pathway on January 4, 1980. Manufactured by Renal Systems, it is classified as a Class 2 device under product code KPO.
What It Is
Renal Systems Hemodialysis Concentrate is a solution used to prepare dialysis fluid in hemodialysis machines. It is essential for removing waste products and excess fluid from the blood of patients with renal failure.
Clinical Applications
This device is commonly used in clinical settings for patients undergoing hemodialysis due to chronic kidney disease. It is crucial in maintaining electrolyte balance and removing toxins during dialysis sessions.
Evidence Summary
The available literature includes 12 studies, ranging from randomized controlled trials to retrospective analyses, published between 2009 and 2023. These studies explore various aspects of dialysis fluid production and its clinical implications.
Reported Outcomes
Published studies report that the use of hemodialysis concentrate is effective in achieving desired dialysis outcomes, such as adequate waste removal and fluid balance. The studies emphasize the importance of proper dialysis fluid preparation in optimizing treatment efficacy.
Safety Profile
Reported complications include potential hemodynamic disturbances and electrolyte imbalances, which can affect myocardial electrophysiology. These issues underscore the need for careful monitoring during dialysis.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies specifically focused on the concentrate's direct impact on patient outcomes. Further research is needed to explore its long-term safety and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for renal systems hemodialysis concentrate?
The device is indicated for use in hemodialysis to prepare dialysis fluid necessary for patients with renal failure.
What outcomes have been reported in clinical studies?
Studies report effective waste removal and fluid balance, highlighting the importance of proper dialysis fluid preparation.
What complications have been reported?
Safety data indicate potential hemodynamic disturbances and electrolyte imbalances during dialysis.
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.