Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-Up Pedi System
510(k) K022747
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022747 | Date11 Feb 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 20 Sep 2026
The Hydropure Portable Exchange Deionization (PEDI) System is a water purification subsystem designed for hemodialysis applications. It removes organic, inorganic substances, and microbial contaminants from water used to dilute dialysis concentrates, ensuring dialysate purity for patient safety. The system operates via exchange deionization to produce high-quality water for hemodialysis processes, including dialyzer reprocessing and equipment rinsing.
The system is supplied as a portable or backup unit, configured for use in hemodialysis settings. It is intended for single-use or reusable components depending on the specific model and application, with production capacities ranging from 250 gallons to 3,600 gallons per deionization tank exchange, depending on feed water quality and flow rate (0.75–15 GPM). The device is regulated under FDA 510(k) clearance (K022747) and adheres to regulatory standards for water purification in medical environments, including compliance with 21 CFR Part 876.5665.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the Hydropure Portable Exchange Deionization (PEDI) System in a hemodialysis setting?
The Hydropure PEDI System is designed to purify water used in hemodialysis by removing organic, inorganic substances, and microbial contaminants. This ensures the production of high-quality dialysate, which is critical for patient safety during dialysis processes like dialyzer reprocessing and equipment rinsing.
How much water can the PEDI System produce per deionization tank exchange, and what factors influence this capacity?
The production capacity of the PEDI System ranges from 250 gallons to 3,600 gallons per deionization tank exchange, depending on the quality of the feed water and the flow rate, which varies between 0.75 GPM and 15 GPM. Lower feed water quality or higher flow rates may reduce the total output per exchange.
Are components of the Hydropure PEDI System intended for single-use or reuse, and how should they be handled?
The Hydropure PEDI System includes both single-use and reusable components, depending on the specific model and application. While the system itself is designed for repeated use, certain consumables (like deionization tanks or cartridges) may require replacement after each exchange or based on manufacturer guidelines to maintain performance and sterility.
What regulatory pathway does the Hydropure PEDI System follow, and what standards does it comply with?
The Hydropure PEDI System is cleared by the FDA under 510(k) (K022747) and adheres to 21 CFR Part 876.5665, which governs water purification devices for medical use. This ensures compliance with strict standards for water quality in hemodialysis environments, including microbial and chemical contaminant limits.
What types of settings or applications is the PEDI System specifically designed for?
The system is configured for hemodialysis settings, including both primary use as a portable water purification subsystem and as a backup unit to ensure uninterrupted dialysate production. It supports critical processes like dialyzer reprocessing and equipment rinsing, where high-purity water is essential.