# K133783: Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Apr 16, 2014 after 125 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: 3 generations back to K894300 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111740: Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station, Ameriwater (2011) Summary page 1.
- K131904: Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System with Heat SA, Ameriwater (2013) Summary page 1.

## Indications for use
The AmeniWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.). standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.

Source page: https://510kreport.com/device/K133783
Methodology: https://510kreport.com/methodology