510(k) · Cleared
ClearedAmeriWater MediQA Reverse Osmosis System (MSP3HF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AmeriWater, LLC · FIP Subsystem, Water Purification
Cleared on Feb 13, 2023 as substantially equivalent to K131904 (Ameriwater, 2013) after a 69-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Feb 13, 2023
- Review
- 69 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931595 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK931595 Reverse Osmosis Equipment for Water PurificationOsmonics, Inc. · 1994
- 2 generations backK974899 Gambro Central Water Treatment System CWP 100 - Wro HGambro Healthcare · 1998 · Recalled
- 1 generation backK131904 Mediqa Single Pass Reverse Osmosis System with Heat Sanitization…Ameriwater · 2013
- This deviceK223656 AmeriWater MediQA Reverse Osmosis System (MSP3HF)AmeriWater, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931595 | Reverse Osmosis Equipment for Water Purification | Osmonics, Inc. | 1994 | — |
| −2 | K974899 | Gambro Central Water Treatment System CWP 100 - Wro H | Gambro Healthcare | 1998 | 2 |
| −1 | K131904 | Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa… | Ameriwater | 2013 | — |
| 0 (this device) | K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FIP device
- #1 K251851 DIASAFEplusUS (F00013010)score 14.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131904 | Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass…Summary page 4…Page 1 of 5 January 31, 2023 510(K) SUMMARY Submission Type: Special 510(K): Device Modification - New Model Existing 510(K) Number: K131904 Submitter: AmeriWater, LLC Contact: Brian R. Bowman, Quality & EHS Manager… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K131904.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FIP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIP
77in 2025
MAUDE reports naming product code FIP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 3 | 202 | 0 | 5 |
| 2009 | 3 | 167 | 0 | 0 |
| 2010 | 2 | — | 0 | 12 |
| 2011 | 4 | 116 | 0 | 4 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | 125 | 0 | 41 |
| 2014 | 4 | 126 | 0 | 34 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 13 |
| 2020 | 1 | — | 1 | 12 |
| 2021 | 1 | — | 0 | 35 |
| 2022 | 1 | — | 0 | 57 |
| 2023 | 3 | 69 | 0 | 140 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 88 | 0 | 77 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (266 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223656 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223656: AmeriWater MediQA Reverse Osmosis System (MSP3HF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026