📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to prepare dialysate for hemodialysis treatment.
- Used with compatible hemodialysis systems to support removal of waste products and excess fluid from the blood.
- Used in the treatment of patients requiring hemodialysis for renal failure.
Clinical Applications
- Preparing dialysis fluid for hemodialysis machines.
- Supporting removal of metabolic waste products during hemodialysis.
- Supporting removal of excess fluid during hemodialysis.
- Helping maintain the intended electrolyte composition of dialysate during treatment.
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.
Practical Considerations
- The concentrate must be used with a compatible dialysis machine and according to the manufacturer's instructions for dilution and preparation.
- Dialysate composition, including electrolyte and buffering components, must be selected and monitored by the dialysis care team for the patient's clinical needs.
- The product is not implanted and is not itself connected directly to the patient's blood; it is used to prepare dialysate within the dialysis system.
- Inspect the container, labeling, expiration date, and solution appearance before use. Do not use compromised or improperly stored product.
- MRI considerations generally apply to the associated dialysis machine and treatment environment rather than to the concentrate itself; the product should not be considered MRI equipment.
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.