đź“‹ FDA Reference
Wro 300 Water Purification System for Hemodialysis
Gambro Renal Products
Summary: The WRO 300 is a water purification system designed for hemodialysis, ensuring safe and clean water for dialysis treatments. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K042797 ↗
Decision Date ?
March 9, 2005
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The WRO 300 water purification system by Gambro Renal Products was cleared through the FDA 510(k) pathway on March 9, 2005. It is classified as a Class 2 device under product code FIP.
What It Is
The WRO 300 is a water purification system specifically designed for use in hemodialysis. It removes contaminants and impurities from water, ensuring it meets the stringent quality standards required for dialysis. The system uses a combination of filtration and reverse osmosis to purify water, providing a reliable source of clean water necessary for safe dialysis treatments.
FDA-Cleared Indications
- Purification of water used for hemodialysis treatments.
Clinical Applications
- Providing purified water for chronic hemodialysis in dialysis centers.
- Providing purified water for hospital-based hemodialysis.
- Supporting acute hemodialysis when dialysis equipment requires a dedicated purified-water supply.
- Integrating with compatible hemodialysis systems as part of a dialysis water-treatment installation.
Practical Considerations
- The system is intended for use with compatible hemodialysis equipment and an appropriately designed water-treatment installation; compatibility should be confirmed before setup.
- Installation, disinfection, filter replacement, water-quality testing and preventive maintenance must follow the manufacturer’s instructions and applicable dialysis-water standards.
- The WRO 300 is a facility water-treatment system, not an implantable device or a direct patient-treatment device.
- MRI safety is generally not the primary consideration because the system is installed in the dialysis or utility area rather than used inside the MRI scanner room; site-specific MRI compatibility should be verified if the system is near an MRI suite.
- The FDA record identifies the device as a Class II system under product code FIP; the available record does not provide a universal service life, flow capacity or patient-specific contraindication list.
Frequently Asked Questions
What is the WRO 300 used for?
The WRO 300 is used to purify water for hemodialysis, ensuring it meets safety and quality standards for dialysis treatments.
What specialties typically use this device?
Nephrologists and dialysis technicians in nephrology departments and dialysis centers typically use this device.
What are the FDA-cleared indications?
The WRO 300 is indicated for purifying water for hemodialysis to ensure safe and effective dialysis treatments.
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.