# K223656: AmeriWater MediQA Reverse Osmosis System (MSP3HF)

- Pathway: 510(k) (Special)
- Applicant: AmeriWater, LLC
- Decided: Feb 13, 2023 after 69 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 K931595 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131904: Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System with Heat SA, Ameriwater (2013) Summary page 4.

## Indications for use
The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. 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 pretreatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process. The MediQA is available in both single pass and double pass models that supply from 4.5 to 16.0 gallons per minute (gpm) of product water. Model MSP1 is a single pass, single membrane RO that produces up to 5.0 gpm of product water. Model MSP2 is a single pass, dual-membrane RO that produces up to 9.4 gpm of product water. Model MSP3 is a single pass, 3-membrane RO that produces up to 12.6 gpm of product water. Model MSP3HF is a high-flow, single pass, 3-membrane RO that produces up to 16.0 gpm of product water. Model MDP1 is a double pass, 2-membrane RO that produces up to 5.0 gpm of product water. Model MDP2 is a double pass, 3-membrane RO that produces up to 7.0 gpm of product water. Model MDP3 is a double pass, 4-membrane RO that produces up to 10.0 gpm of product water. Model MDP4 is a double pass, 5-membrane RO that produces up to 12.0 gpm of product water.

Source page: https://510kreport.com/device/K223656
Methodology: https://510kreport.com/methodology