# K142285: AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Dec 1, 2014 after 105 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 K882564 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093641: TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC (2010) Summary page 4.

## Indications for use
The AmeriWater Heatsan is an optional accessory for water treatment systems intended for use in hemodialysis applications. The Heatsan is designed to heat water received from the water purification system, and circulate the heated water around the distribution loop at a controlled sanitizing temperature (minimum temperature of 185°F) for a programmed length of time (minimum hold time of 2 hours) to provide heat disinfection of the water distribution loop. The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml.

Source page: https://510kreport.com/device/K142285
Methodology: https://510kreport.com/methodology