# K022747: Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi System

- Pathway: 510(k) (Traditional)
- Applicant: Hydropure Systems, Inc.
- Decided: Feb 11, 2003 after 176 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) US Filter Corporation’s water treatment system for dialysis: named in the summary without a submission number

## Most influential descendants
- K042089: NX Stage Water Purification System (2004), 0 descendants of its own
- K031832: Mega Pure Cart (2004), 0 descendants of its own

## Indications for use
The HydroPure “Acute” Portable Exchange Deionization (PEDI) System consists of two each small carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be placed on the back of a dialysis machine or on a handcart for single patient dialysis. The HydroPure “Central” PEDI System consists of two or more carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be installed in a central location for multiple patient dialysis. The HydroPure “Back-up” PEDI System consists of two or more mixed bed DI tanks as a component in a “back-up” condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions that an RO could not lower to safe levels. All three PEDI systems with appropriate pre & post-filtration and components is intended for use with a hemodialysis system to remove organic and inorganic substances from water that is used to dilute dialysis concentrates to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.

Source page: https://510kreport.com/device/K022747
Methodology: https://510kreport.com/methodology