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Dayton Water Systems Ultrapure Water Treatment Systems for Hemodialysis
Dayton Water Systems
Summary: The Dayton Water Systems Ultrapure Water Treatment Systems are designed for hemodialysis, ensuring the purity of water used in dialysis treatments. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021352 ↗
Decision Date ?
August 1, 2002
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on August 1, 2002, by Dayton Water Systems. It is classified as a Class 2 device under product code FIP.
What It Is
The Dayton Water Systems Ultrapure Water Treatment Systems are specialized devices used to purify water for hemodialysis. These systems remove contaminants and ensure that the water meets stringent quality standards necessary for patient safety during dialysis. The device typically includes components like filters and reverse osmosis units to achieve ultrapure water quality.
FDA-Cleared Indications
- Treatment of water used for hemodialysis.
- Production of appropriately purified water for use with hemodialysis equipment.
Clinical Applications
- Water treatment in hospital hemodialysis units.
- Water treatment in outpatient dialysis centers.
- Preparation of water used to make dialysate for patients receiving maintenance hemodialysis.
- Integration with compatible dialysis water-distribution and dialysis equipment.
Practical Considerations
- The system must be sized to match the number of dialysis stations, required flow rate, and facility water demand.
- Compatibility with the dialysis machines, pretreatment equipment, distribution loop, plumbing, and monitoring instruments should be confirmed before installation.
- Routine disinfection, filter replacement, maintenance, and water-quality testing are necessary; schedules should follow the manufacturer’s instructions and applicable dialysis-water standards.
- This is a facility water-treatment system, not an implantable device or a device placed in a patient.
- MRI safety labeling is generally not the primary issue because the system is installed in the dialysis facility; any components located near an MRI suite should be assessed for ferromagnetic materials and site-specific MRI requirements.
Frequently Asked Questions
What is Dayton Water Systems Ultrapure Water Treatment Systems used for?
It is used to purify water for hemodialysis, ensuring the water meets safety standards for dialysis treatments.
What specialties typically use this device?
Nephrology and dialysis centers use this device, primarily operated by nephrologists and dialysis technicians.
What are the FDA-cleared indications?
The device is indicated for treating water used in hemodialysis to ensure it is free from harmful contaminants.
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.