# K042018: Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-UP Pedi System

- Pathway: 510(k) (Traditional)
- Applicant: Simply Clean Air & Water, Inc.
- Decided: Apr 15, 2005 after 262 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
Systems are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers, equipment rinse and disinfection. The Acute PEDI System consists of a sediment filter, carbon filtration, mixed bed deionizers, endotoxin filter and system monitoring with remote alarm functions. It is intended for use in a location with a portable dialysis machine for the dialysis of a single patient. The Central PEDI System consists of a booster pump / pressure tank assembly, sediment filter, carbon filtration, mixed bed deionizers, resin trap filter, endotoxin filter and system monitoring with flow isolation/divert and remote alarm functions. It is intended for use in a central location for the dialysis of multiple patients. The Back-up PEDI System consists of mixed bed deionizers, intermediate water quality (QC) indicator (light) and connection hoses. It is intended for use to provide a "back-up" for reverse osmosis unit repair or to "polish" the product outlet of a RO to meet AAMI RD62:2001 requirements. Endotoxin filtration and system monitoring with flow isolation / divert and remote alarm functions are provided when required to meet ANSI/AAMI RD62:2001 requirements.

Source page: https://510kreport.com/device/K042018
Methodology: https://510kreport.com/methodology