đź“Š Evidence-Based Reference
Gambro Hemodialysis Water Treatment System
Gambro Healthcare
Summary: The Gambro Hemodialysis Water Treatment System is designed for water purification in hemodialysis. It is primarily used to ensure safe and effective dialysis treatment. Key evidence highlights its role in maintaining dialysate quality and system reliability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981085 ↗
Decision Date ?
May 18, 1998
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The Gambro Hemodialysis Water Treatment System was cleared by the FDA via the 510(k) pathway on May 18, 1998. It is manufactured by Gambro Healthcare and classified as a Class 2 device.
What It Is
The Gambro Hemodialysis Water Treatment System is a device that purifies water for hemodialysis, ensuring the removal of contaminants to produce safe dialysis fluid. It is intended for use in clinical settings to support dialysis treatment.
FDA-Cleared Indications
- Water treatment for use in hemodialysis.
- Purification of water used to prepare dialysis fluid.
Clinical Applications
- Treating water supplied to a hemodialysis unit.
- Supporting preparation of dialysate for routine hemodialysis.
- Use in hospitals, outpatient dialysis centers, and other clinical dialysis facilities that require treated water.
Evidence Summary
The available literature includes 9 studies ranging from 2004 to 2025, covering various aspects of dialysis water treatment. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the Gambro system effectively maintains dialysate quality and supports reliable dialysis treatment. It has been associated with improved dialysis outcomes, such as reduced inflammation and prevention of dialysis-related complications.
Safety Profile
Reported complications include system failures related to PC PLC issues, which can affect water supply. However, troubleshooting methods have been developed to address these issues effectively.
Evidence Limitations
The evidence is limited by the variability in study designs and the need for more comprehensive safety data. Further research is needed to explore long-term outcomes and system improvements.
Practical Considerations
- The system is facility-based equipment rather than an implantable or patient-worn device.
- Performance depends on the incoming water supply, pretreatment components, installation, maintenance, and scheduled microbiological and chemical testing.
- It must be used with compatible dialysis equipment and according to the manufacturer’s instructions and applicable water-quality standards.
- The system does not replace routine dialysis-machine disinfection, water-quality monitoring, or maintenance of the broader dialysis water system.
- MRI compatibility is generally not a relevant designation for a fixed water-treatment system; keep equipment and controls outside restricted MRI areas unless the specific configuration has been evaluated.
Frequently Asked Questions
What are the clinical indications for Gambro Hemodialysis Water Treatment System?
The system is indicated for use in purifying water for hemodialysis, ensuring safe and effective dialysis treatment.
What outcomes have been reported in clinical studies?
Studies have reported improved dialysate quality and reliable system performance, contributing to better dialysis outcomes.
What complications have been reported?
Safety data indicate potential system failures due to PC PLC issues, but troubleshooting methods are available.
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.