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nelson water systems for hemodialysis
Nelson Environmental Technologies
Summary: Nelson Water Systems for hemodialysis is a device used to purify water for dialysis treatment. It is primarily used in clinical settings to ensure safe and effective dialysis. Key evidence highlights the device's role in maintaining water quality for hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K993877 ↗
Decision Date
May 25, 2000
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The Nelson Water Systems for hemodialysis was cleared by the FDA through the 510(k) pathway on May 25, 2000. It is manufactured by Nelson Environmental Technologies and classified as a Class 2 device.
What It Is
Nelson Water Systems for hemodialysis is designed to purify water used in dialysis treatments. It removes contaminants to ensure water safety and quality, which is critical for effective hemodialysis. The system is intended for use in healthcare facilities providing dialysis services.
Clinical Applications
This device is commonly used in dialysis centers and hospitals to provide purified water for hemodialysis treatments. It is essential in maintaining the safety and efficacy of dialysis by preventing waterborne contaminants from affecting patient outcomes.
Evidence Summary
The available literature includes five studies, with types ranging from randomized controlled trials to retrospective analyses. The studies span from 2019 to 2023, providing insights into the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Nelson Water Systems effectively maintain water quality for hemodialysis, contributing to improved patient outcomes. The device supports the removal of higher molecular weight uremic retention solutes, enhancing dialysis efficacy. However, specific quantitative outcomes from these studies are not detailed.
Safety Profile
Reported complications include concerns regarding the online production of large volumes of sterile, nonpyrogenic replacement fluid. However, no specific adverse events directly related to the device's use were highlighted in the provided evidence.
Evidence Limitations
The evidence provided lacks detailed quantitative outcomes and specific adverse event data. Further research is needed to explore long-term safety and efficacy, as well as to address regulatory concerns regarding online fluid production.
Frequently Asked Questions
What are the clinical indications for Nelson Water Systems for hemodialysis?
The device is indicated for use in purifying water for hemodialysis treatments, ensuring safe and effective dialysis by removing contaminants.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of water quality for hemodialysis, contributing to improved patient outcomes by supporting solute removal.
What complications have been reported?
Safety data indicate concerns with online production of sterile fluids, but no specific adverse events directly related to the device were reported.
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.