Pure Water-CDS Central Dialysis Solution
by Pure Water Solutions, Inc. 510(k)
Active
510(k) K994279
Overview
The Pure Water-CDS Central Dialysis Solution is a water purification subsystem designed to prepare high-purity water for hemodialysis treatment. It employs multi-media filtration, water softening, granular activated carbon, reverse osmosis (RO), and deionization (DI) to remove suspended solids, hardness, chlorine, chloramines, and other contaminants, ensuring safe and compliant dialysis fluid production.
This system is intended for use in hemodialysis clinics and is supplied as a reusable, centralized water purification unit. It adheres to regulatory standards under 21 CFR 876.5665 and holds an FDA 510(k) clearance (K994279) as a substantially equivalent device. The device is not single-use and requires proper installation, maintenance, and storage in accordance with manufacturer guidelines to ensure consistent performance and water quality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994279 | Date22 Dec 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FIP
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5665
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pure Water Solutions, Inc.
Questions
What is the Pure Water-CDS Central Dialysis Solution used for?
The Pure Water-CDS is designed to prepare high-purity water for hemodialysis treatments. It employs a multi-stage filtration process—including multi-media filtration, water softening, granular activated carbon, reverse osmosis (RO), and deionization (DI)—to remove suspended solids, hardness, chlorine, chloramines, and other contaminants. This ensures the production of safe and compliant dialysis fluid, meeting regulatory standards for hemodialysis clinics.
Is the Pure Water-CDS a single-use or reusable device?
The Pure Water-CDS is a reusable, centralized water purification unit. It is not intended for single-use and requires proper installation, maintenance, and storage to ensure consistent performance and water quality over repeated use in hemodialysis settings.
What regulatory standards does the Pure Water-CDS adhere to?
The device adheres to the regulatory standards outlined in 21 CFR 876.5665 for water purification systems used in hemodialysis. It also holds an FDA 510(k) clearance (K994279), confirming it is substantially equivalent to a legally marketed predicate device under the Abbreviated 510(k) pathway.
How should the Pure Water-CDS be stored and maintained?
The Pure Water-CDS requires proper installation, maintenance, and storage as specified by the manufacturer to ensure consistent performance and water quality. Regular upkeep—including filter replacements, system cleaning, and compliance with manufacturer guidelines—is essential to prevent contamination and maintain regulatory compliance for hemodialysis applications.
What types of contaminants does the Pure Water-CDS remove from water?
The system removes a range of contaminants, including suspended solids, hardness (calcium and magnesium ions), chlorine, chloramines, organic impurities, and other dissolved minerals. The multi-stage filtration process—combining physical, chemical, and ion-exchange methods—ensures water purity suitable for hemodialysis treatment.