# K121022: Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity, Base Model & Remote with Resistiv

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Sep 17, 2012 after 166 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: 2 generations back to K894300 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991519: Ameriwater Purification System for Hemodialysis, Ameriwater (2000) Summary page 1.

## Indications for use
The AmerWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeniWater Water Purification System (WPS) for hemodialysis applications. The AmeniWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operators attention. The AmeniWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards. Model 00850250 -Base Model & Remote Panel. This model includes RIO Alarm, Low Storage Tank, and Low Bicarb. there are also 5 additional dry contact inputs. When one of these receives a closure from the external source, such as a low tank level in a chemical feed system, the LCD will indicate an alarm and display the input number in the alarm display. The alarm panel also includes an Alarm Silence function. The Remote is installed at the Nurse's Station on the treatment floor. It has a set of lights and audible alarm that corresponds to what is indicated on the main panel in the water room however there is no "Alarm Silence" available on the Remote Panel. To silence the alarm, it will require the users attention in the water room. Model 00850251 - Base Model & Remote with Conductivity. This model includes all of the features of the base model with the addition of a conductivity sensor and high conductivity alarm. The Alarm Panel can be used to power solenoid valves to divedt the water flow to the drain when the conductivity is above the set-point. Model 00850252 - Base Model & Remote with Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a resistivity sensor and low resistivity alarm with dump valve. The Alarm Panel can be used to power solenoid valves to divedt the water flow to the drain when the resistivity is below the set-point. A solenoid valve (dump valve) is included with this model to divert water to drain during a low resistivity alarm condition. Model 00850253 - Base Model & Remote with Conductivity, Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a conductivity sensor, high conductivity alarm, resistivity sensor, and low resistivity alarm with dump valve.

Source page: https://510kreport.com/device/K121022
Methodology: https://510kreport.com/methodology