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pure water solutions central water system for hemodialysis
Pure Water Solutions
Summary: The Pure Water Solutions Central Water System is designed for hemodialysis applications, providing purified water. It is FDA 510k cleared with evidence from 15 studies supporting its use in dialysis settings.
FDA Clearance Information
Pathway
510K
Number
K011005 ↗
Decision Date
November 1, 2002
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The Pure Water Solutions Central Water System for hemodialysis was cleared by the FDA via the 510k pathway on November 1, 2002. It is manufactured by Pure Water Solutions and classified as a Class 2 device.
What It Is
The device is a central water purification system intended for use in hemodialysis. It ensures the delivery of high-quality water necessary for dialysis treatments, reducing contaminants that could affect patient safety.
Clinical Applications
Commonly used in dialysis centers, this device supports the purification of water for hemodialysis, ensuring compliance with safety standards. It is critical in settings where large volumes of purified water are required for patient treatments.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and prospective studies, published between 2023 and 2025. These studies provide insights into the device's performance and safety in clinical settings.
Reported Outcomes
Published studies report that the Pure Water Solutions Central Water System effectively reduces water contaminants, supporting safe hemodialysis treatments. The system's reliability in maintaining water quality standards is consistently noted across studies.
Safety Profile
Reported complications include minimal adverse events related to water quality, with studies indicating a high safety profile for the device. No significant safety concerns have been identified in the available literature.
Evidence Limitations
Current evidence lacks long-term follow-up data on device performance. Further research is needed to explore the system's efficacy in diverse clinical environments and its impact on patient outcomes over extended periods.
Frequently Asked Questions
What are the clinical indications for pure water solutions central water system for hemodialysis?
The device is indicated for use in hemodialysis settings to provide purified water necessary for dialysis treatments.
What outcomes have been reported in clinical studies?
Studies report effective reduction of water contaminants and reliable maintenance of water quality standards for hemodialysis.
What complications have been reported?
Safety data indicate minimal adverse events, with no significant safety concerns identified in the studies reviewed.
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.