510(k) · Cleared
ClearedMroz Reverse Osmosis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIP Subsystem, Water Purification
Cleared on Sep 20, 2013 as substantially equivalent to K924695 (Dayton Water Systems, 1995) and 2 other predicates after a 109-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Sep 20, 2013
- Review
- 109 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K894300 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK894300 Submersible Reverse Osmosis Water Purification SysU.S. Filter/Continental Water Systems · 1990
- 2 generations backK991519 Ameriwater Purification System for HemodialysisAmeriwater · 2000
- 1 generation backK111740 Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1…Ameriwater · 2011 · Recalled
- This deviceK131622 Mroz Reverse Osmosis SystemAmeriwater · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | 1990 | — |
| −2 | K991519 | Ameriwater Purification System for Hemodialysis | Ameriwater | 2000 | — |
| −1 | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station | Ameriwater | 2011 | 1 |
| 0 (this device) | K131622 | Mroz Reverse Osmosis System | Ameriwater | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (3)
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…Gastroenterology Product Code: FIP Predicate Devices: AmeniWater Aseptech Portable RO+ cleared for market under K924695, AmeniWater MRO systems included in K<991 519, AmenWate… | 1995 |
| * | K991519 | Ameriwater Purification System for HemodialysisSummary page 2…quivalence: The AmeriWater MRQZ is substantially equivalent to the Aseptech Portable RO+ cleared for market under K924695, the AmeriWater MROD systems included in K991 519, and the AmeniWater MRO Portable RO System cleared for market under KI 11740. The MROZ is the same in design, opera… | 2000 |
| * | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationSummary page 1…AmeniWater MRO systems included in K<991 519, AmenWater MRO Portable RO System cleared for market under 1111740 Device Description: The AmeniWater MROZ Reverse Osmosis System is a water treatment system intended for use in hem… | 2011 |
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 23 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2013, 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 AmenWater MROZ Reverse Osmosis System is a water treatment device Intended for use In heniodlalysis applications, It Is intended to be used as a component In the AmenWater Water Purification System (K(991519), and Isintended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmenWater MROZ Isintended for use in water moms insa hospital, clinic, or dialysis center. The device…
Read the full statement (263 words)
The AmenWater MROZ Reverse Osmosis System is a water treatment device Intended for use In heniodlalysis applications, It Is intended to be used as a component In the AmenWater Water Purification System (K(991519), and Isintended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmenWater MROZ Isintended for use in water moms insa hospital, clinic, or dialysis center. The device is Intended to be a component ina complete water purification system, and Isnot a complete water treatment system. It must be proceeded by pme-treatment devices, and may need to be followed by past-treatment devices as well to meet current MAMI and Federal (U.S.) standards.
Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water. Model MR04Z ls a4 membrane system designed to supply 8,800 gpd! of product water. Model MR05Z Is a 5 membrane system designed to supply 11,000 gpd! of product water. Model MROBZ is686 membrane systemns designed to supply 13,200 gpd of product water. Model MRO7Z Is a 7 membrane system designed to supply 15,400 gpd! of product water. Model MRO8Z is n 8 membrane system designed to supply 17,600 gpd of product water. Each model is available in a 208V, 230V, or 460V variant and Includes a divert- to-drain feature to prevent patient exposure to unsafe product water. Each model Includes temperature compensated online monitors that display conductivity and percent rejection. The conductivity monitor activates an audible and visual alarm when the product water conductivity exceeds a preset alarm limit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131622: Mroz Reverse Osmosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131622
Report an extraction error
Are you the manufacturer?
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