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water purification system for hemodialysis
Better Water
Summary: The water purification system for hemodialysis by Better Water is designed to ensure the purity of water used in dialysis treatments. Key evidence highlights the importance of maintaining water quality to prevent adverse effects and improve patient outcomes.
FDA Clearance Information
Pathway
510K
Number
K920186 ↗
Decision Date
June 13, 1995
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on June 13, 1995. It is manufactured by Better Water and classified as a Class 2 device under product code FIP.
What It Is
This device is a water purification system specifically designed for hemodialysis. It ensures the removal of contaminants from water used in dialysis, which is critical for patient safety and effective treatment.
Clinical Applications
Commonly used in dialysis centers, hospitals, and clinics, this device is essential for preparing water that meets safety standards for hemodialysis. It is crucial in preventing chemical hazards and bioincompatibility reactions.
Evidence Summary
The literature includes 14 studies, spanning from 2019 to 2025, comprising RCTs, prospective, retrospective, and other study types. These studies emphasize the significance of water purity in dialysis.
Reported Outcomes
Published studies report that maintaining high water quality in hemodialysis reduces chemical hazards and adverse effects related to bioincompatibility. Improved water purity is associated with enhanced long-term patient outcomes.
Safety Profile
Reported complications include potential chemical hazards and adverse effects from contaminated water. Ensuring compliance with international standards is critical to mitigating these risks.
Evidence Limitations
Current evidence highlights the need for further research on long-term outcomes and the effectiveness of different water purification technologies. Some studies lack large sample sizes and comprehensive safety data.
Frequently Asked Questions
What are the clinical indications for the water purification system for hemodialysis?
The device is indicated for use in hemodialysis to ensure water purity and prevent adverse effects from contaminated water.
What outcomes have been reported in clinical studies?
Studies report that high water quality reduces chemical hazards and improves patient outcomes in hemodialysis.
What complications have been reported?
Reported complications include chemical hazards and adverse effects from contaminated water, underscoring the need for compliance with standards.
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.