510(k) · Cleared
Recalled · Class II · 2012Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIP Subsystem, Water Purification
Cleared on Oct 5, 2011 as substantially equivalent to K924695 (Dayton Water Systems, 1995) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 5, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- FIP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894300 (1990). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK894300 Submersible Reverse Osmosis Water Purification SysU.S. Filter/Continental Water Systems · 1990
- 1 generation backK991519 Ameriwater Purification System for HemodialysisAmeriwater · 2000
- This deviceK111740 Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1…Ameriwater · 2011
- Descendant · cites it directly · 0 of its ownK133783 Ameriwater Centurion 1500+ Reverse Osmosis System with Heat…Ameriwater · 2014
- Descendant · cites it directly · 0 of its ownK131622 Mroz Reverse Osmosis SystemAmeriwater · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | 1990 | — |
| −1 | K991519 | Ameriwater Purification System for Hemodialysis | Ameriwater | 2000 | — |
| 0 (this device) | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station | Ameriwater | 2011 | — |
| +1 | K133783 | Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization | Ameriwater | 2014 | — |
| +1 | K131622 | Mroz Reverse Osmosis System | Ameriwater | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K924695 | Aseptech Portable RO+ SystemSummary page 1…5 Panel: Gastroenterology Product Code: FIP Equivalent Device: K924695, AmerWater (Dayton Water Systems) Aseptech Portable RO+ system K991 519, AmeniWater Wate… | 1995 |
| * | K991519 | Ameriwater Purification System for HemodialysisSummary page 1…uct Code: FIP Equivalent Device: K924695, AmerWater (Dayton Water Systems) Aseptech Portable RO+ system K991 519, AmeniWater Water Purification System Device Description: Osmosis is a natural process where two liquids of different… | 2000 |
| † | K110285 | Nephros Dsu Filter, Nephros Msu Filter, Nephros Ssu Filter | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2012 | Class II | Z-2321-2012 | Nonconforming Material/Component | The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133783 (Ameriwater, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K924695.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AmeniWater MRO Portable 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 AmeniWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeniWater Portable MR01 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111740: Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111740
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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