📋 FDA Reference
Isopure Complete Water System for Hemodialysis Md 400 and Md 600 Series
Isopure
Summary: The Isopure Complete Water System for Hemodialysis is a device used to purify water for dialysis treatments. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K041163 ↗
Decision Date ?
October 7, 2004
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The Isopure Complete Water System was cleared through the FDA 510k pathway on October 7, 2004. Manufactured by Isopure, it is classified as a Class 2 device under product code FIP.
What It Is
The Isopure Complete Water System is designed to provide high-quality water for hemodialysis treatments. It removes impurities and contaminants from water, ensuring it meets the stringent standards required for dialysis. This system is crucial in preventing complications that can arise from impure water during dialysis sessions.
FDA-Cleared Indications
- Purification of water for use in hemodialysis.
Clinical Applications
- Providing treated water to hemodialysis systems in hospitals.
- Providing treated water to hemodialysis systems in outpatient dialysis centers.
- Supporting dialysis treatment for patients with kidney failure when used as part of a complete hemodialysis water system.
Practical Considerations
- The MD 400 and MD 600 series have different system configurations or capacities; the selected model should match the dialysis unit's water demand and installation requirements.
- The system is facility equipment and must be installed, operated, disinfected, monitored, and maintained according to the manufacturer's instructions and applicable dialysis-water standards.
- Compatibility with dialysis machines, pretreatment equipment, plumbing, storage tanks, alarms, and distribution loops should be confirmed before installation.
- This is not an MRI device and is not placed in or on a patient; MRI safety considerations relate to whether the equipment is installed near the MRI environment.
- The system does not replace routine water-quality testing, preventive maintenance, or required monitoring for chemical and microbiologic contaminants.
Frequently Asked Questions
What is the Isopure Complete Water System used for?
It is used to purify water for hemodialysis treatments, ensuring the water meets safety standards.
What specialties typically use this device?
Nephrology and dialysis centers primarily use this device.
What are the FDA-cleared indications?
The device is indicated for purifying water for use in hemodialysis, ensuring it is safe and free from 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.