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Ultrapure Water Treatment System for Hemodialysis
Dayton Water Systems
Summary: The ultrapure water treatment system by Dayton Water Systems is designed for hemodialysis. It is FDA 510k cleared and supported by 14 studies focusing on water purification technologies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981680 ↗
Decision Date ?
December 31, 1998
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The ultrapure water treatment system was cleared by the FDA via the 510k pathway on December 31, 1998. Manufactured by Dayton Water Systems, it is classified as a Class 2 device.
What It Is
This device is an ultrapure water treatment system used in hemodialysis to ensure the removal of contaminants from water. It employs technologies like reverse osmosis and ion exchange to produce water that meets stringent purity standards.
FDA-Cleared Indications
- For treating water used in hemodialysis.
- For reducing chemical, microbial, and other contaminants in water used for dialysis, according to the manufacturer's labeling.
Clinical Applications
- Producing treated water for hemodialysis machines.
- Supporting water purification in outpatient dialysis centers.
- Supporting water purification in hospital-based dialysis units.
- Providing treated water for dialysis treatment preparation and operation.
Evidence Summary
The literature includes 14 studies, with various methodologies such as RCTs and case series, published between 2023 and 2025. These studies explore different water purification technologies and their effectiveness.
Reported Outcomes
Published studies report the successful removal of contaminants such as urea and organic micropollutants using advanced filtration methods. The integration of technologies like reverse osmosis and capacitive deionization has shown high efficacy in producing ultrapure water.
Safety Profile
Reported complications include potential membrane fouling and the need for regular maintenance to ensure optimal performance. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the focus on specific contaminants. Further research is needed to evaluate long-term performance and the impact of different water sources on system efficacy.
Practical Considerations
- The system is a facility-based water-treatment system rather than an implantable or patient-contact device.
- Installation requires compatibility with the facility's incoming water supply, plumbing, pretreatment equipment, dialysis machines, and water-quality monitoring program.
- Reverse-osmosis membranes, ion-exchange components, filters, and other consumable parts require scheduled maintenance and replacement.
- Water quality must be tested and monitored according to applicable dialysis standards, facility protocols, and manufacturer instructions.
- MRI safety is generally not the primary issue because the system is not used inside the MRI scanner; metallic components and installation location should still be evaluated before use near MRI equipment.
Frequently Asked Questions
What are the clinical indications for ultrapure water treatment system?
The system is indicated for use in hemodialysis to ensure the water used is free from harmful contaminants.
What outcomes have been reported in clinical studies?
Studies report effective removal of contaminants like urea and organic micropollutants, ensuring high water purity.
What complications have been reported?
Safety data indicate potential membrane fouling and maintenance needs, but no significant adverse events 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.