510(k) · Cleared
ClearedHemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange, Model .60MAW,1.2MAW,3.6MAW, 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Aqua, LLC (Dba Aqua Systems) · FIP Subsystem, Water Purification
Cleared on Apr 2, 2010 as substantially equivalent to K991519 (Ameriwater, 2000) after a 232-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 2, 2010
- Review
- 232 days
- Class
- Class II
- Product code
- FIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894300 (1990). No later device cites it as a predicate yet.
- 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 deviceK092481 Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed…New Aqua, LLC (Dba Aqua Systems) · 2010
View 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) | K092481 | Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer… | New Aqua, LLC (Dba Aqua Systems) | 2010 | — |
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 |
|---|---|---|---|
| * | K991519 | Ameriwater Purification System for HemodialysisSummary page 1…ket. The tanks are designed to supply AAMI standard water for dialysis through ion exchange. The tanks are based on the AmeniWater Dialysis Deionizer Exchange Tanks 1K991519. 6. Indications for use: The Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodi… | 2000 |
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 20 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- None of the 2 ancestors has a recall.
- 9 other devices also cite its predicate K991519.
How does its category compare?
All FIP devicesFIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing…
Read the full statement (115 words)
The Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone.
Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092481: Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange, Model .60MAW,1.2MAW,3.6MAW, 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092481
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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