# K071104: Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi System

- Pathway: 510(k) (Traditional)
- Applicant: Flier'S Quality Water Systems, Inc.
- Decided: Jan 14, 2008 after 270 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
Longest line of descent: 1 generation back to K980182 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980182: Water Purification System for Hemodialysis, Usfilter/Ionpure, Inc. (1998) Summary page 1.

## Indications for use
Flier's Quality Water Systems, Inc. systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001. They remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, in the reprocessing of hemodialyzers, and equipment rinse and disinfection. The Acute System #1 consists of two each carbon and mixed bed DI tanks with pre & post filtration. It is intended to be placed on the back of dialysis machine or on a handcart for single patient dialysis. Acute System #2 consists of just carbon tanks and is intended to be used as pretreatment to a single patient RO system. The Central System #1 and #2 consists of two or more carbon and mixed bed DI tanks with pre & post filtration. They are used as either a temporary system to feed multiple dialysis machines in normal use, or for a system to feed a biomedical technician service station. For permanent, multiple station dialysis clinics Flier's recommends using central water treatment systems including reverse osmosis. The Back-up System #1 and #2 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 from an RO stream to meet AAMI RD62:2001 requirements. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These systems are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Flier's systems are not to be used alone.

Source page: https://510kreport.com/device/K071104
Methodology: https://510kreport.com/methodology