510(k) · Cleared
ClearedMediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System with Heat SA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIP Subsystem, Water Purification
Cleared on Nov 13, 2013 as substantially equivalent to K974899 (Gambro Healthcare, 1998) after a 141-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 13, 2013
- Review
- 141 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931595 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931595 Reverse Osmosis Equipment for Water PurificationOsmonics, Inc. · 1994
- 1 generation backK974899 Gambro Central Water Treatment System CWP 100 - Wro HGambro Healthcare · 1998 · Recalled
- This deviceK131904 Mediqa Single Pass Reverse Osmosis System with Heat Sanitization…Ameriwater · 2013
- Descendant · cites it directly · 0 of its ownK223656 AmeriWater MediQA Reverse Osmosis System (MSP3HF)AmeriWater, LLC · 2023
- Descendant · cites it directly · 0 of its ownK133783 Ameriwater Centurion 1500+ Reverse Osmosis System with Heat…Ameriwater · 2014
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 | K931595 | Reverse Osmosis Equipment for Water Purification | Osmonics, Inc. | 1994 | — |
| −1 | K974899 | Gambro Central Water Treatment System CWP 100 - Wro H | Gambro Healthcare | 1998 | 2 |
| 0 (this device) | K131904 | Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa… | Ameriwater | 2013 | — |
| +1 | K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | 2023 | — |
| +1 | K133783 | Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization | Ameriwater | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K974899 | Gambro Central Water Treatment System CWP 100 - Wro HSummary page 1…Device under §876.5665 Panel: Gastroenterology Product Code: FIP Equivalent Device: K974899, Gambro Central Water Treatment System CWP 100 - WRO H Device Description: Reverse osmosis, the scientific concept used i… | 1998 |
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)
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 19 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K223656 (AmeriWater, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K974899.
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 AmeniWater 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 pre-treatment devices, and may need to be followed by post-treatment devices as well to meet…
Read the full statement (249 words)
The AmeniWater 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 pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The Amen Water 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 12.0 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 MOPi 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 as stated in the FDA summary.
https://510kreport.com/device/K131904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131904: Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System with Heat SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131904
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