510(k) · Cleared
ClearedAmeriwater Purification System for Hemodialysis
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 14, 2000 as substantially equivalent to K894300 (U.S. Filter/Continental Water Systems, 1990) after a 350-day review. Its family tree reaches back 1 generation to 1990. 11 later devices descend from it.
- Decided
- Apr 14, 2000
- Review
- 350 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894300 (1990). 11 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK894300 Submersible Reverse Osmosis Water Purification SysU.S. Filter/Continental Water Systems · 1990
- This deviceK991519 Ameriwater Purification System for HemodialysisAmeriwater · 2000
- Descendant · cites it directly · 2 of its ownK111740 Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1…Ameriwater · 2011 · Recalled
- Descendant · 2 generations on · 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
- Descendant · cites it directly · 0 of its ownK123282 Deonization Exchange Tanks, Carbon Exchange TanksUltrapure & Industrial Services, LLC · 2013
- Descendant · cites it directly · 0 of its ownK121022 Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote…Ameriwater · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K111740Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater · 2011 · cites it directly2descendants
- K133783Ameriwater Centurion 1500+ Reverse Osmosis System with Heat SanitizationAmeriwater · 2014 · 2 generations on0descendants
- K131622Mroz Reverse Osmosis SystemAmeriwater · 2013 · cites it directly0descendants
- K123282Deonization Exchange Tanks, Carbon Exchange TanksUltrapure & Industrial Services, LLC · 2013 · cites it directly0descendants
- K121022Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity…Ameriwater · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | 1990 | — |
| 0 (this device) | 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 |
| +2 | K133783 | Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization | Ameriwater | 2014 | — |
| +1 | K131622 | Mroz Reverse Osmosis System | Ameriwater | 2013 | — |
| +1 | K123282 | Deonization Exchange Tanks, Carbon Exchange Tanks | Ultrapure & Industrial Services, LLC | 2013 | — |
| +1 | K121022 | Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with… | Ameriwater | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K894300 | Submersible Reverse Osmosis Water Purification SysSummary page 1…lyzer reuse. It is AmeriWater's contention that the system is substantially equivalent to the Reverse Osmosis Water Purification System; Continental Water Systems Corp. (K894300) and other systems currently legally marketed in the U.S. The components may include all or some of the following: Tempering val… | 1990 |
What descends from it? (11)
See all 1110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111740 | Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station | 2011 | 2 |
| K131622 | Mroz Reverse Osmosis System | 2013 | 0 |
| K123282 | Deonization Exchange Tanks, Carbon Exchange Tanks | 2013 | 0 |
| K121022 | Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity… | 2012 | 0 |
| K102892 | Asi Deionizer & Carbon Exchange Service for Hemodialysis | 2011 | 0 |
| K092481 | Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange… | 2010 | 0 |
| K083712 | Water Purification Components for Hemodialysis | 2009 | 0 |
| K082400 | Deionizer and Carbon Exchange Service for Hemodialysis | 2009 | 0 |
| K080703 | Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank | 2008 | 0 |
| K072158 | Aqua Pure Deionizer Exchange Service | 2008 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K111740 (Ameriwater, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PURIFICATION SYSTEM FOR HEMODIALYSIS is intended to be used in hemodialysis to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare and dilute solutions for reprocessing procedures in multiple-use dialyzers. AmeriWater does not recommend nor endorse…
Read the full statement (112 words)
The AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is intended to be used in hemodialysis to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare and dilute solutions for reprocessing procedures in multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment.
NOTE* Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.
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/K991519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991519: Ameriwater Purification System for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991519
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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