510(k) · Cleared
ClearedAmeriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIP Subsystem, Water Purification
Cleared on Apr 16, 2014 as substantially equivalent to K111740 (Ameriwater, 2011) and 1 other predicate after a 125-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Apr 16, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894300 (1990). 7 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 deviceK133783 Ameriwater Centurion 1500+ Reverse Osmosis System with Heat…Ameriwater · 2014
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) | K133783 | Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization | Ameriwater | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2013 | 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 14.1 · 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 |
|---|---|---|---|
| * | K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationSummary page 1…Product Code: FIP Equivalent Devices: K1 31 904, Amen Water MediQA Reverse Osmosis System K1 11740, Amen Water MRO Portable Reverse Osmosis System MROS Device Description: The AmeniWater Centurion 1500+ Reverse Osmosis S… | 2011 |
| * | K131904 | Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass…Summary page 1…§876.5665 Panel: Gastroenterology Product Code: FIP Equivalent Devices: K1 31 904, Amen Water MediQA Reverse Osmosis System K1 11740, Amen Water MRO Portable Reverse Osmosis… | 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 24 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K111740.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Centurion 1500+ 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 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…
Read the full statement (122 words)
The AmeniWater Centurion 1500+ 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 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 Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133783: Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133783
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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