510(k) · Cleared
ClearedAmeriwater Solution Mix and Distribution System for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameriwater · FIN Tank, Holding, Dialysis
Cleared on Jan 6, 2006 as substantially equivalent to K992793 (Better Water, Inc., 1999) after a 259-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jan 6, 2006
- Review
- 259 days
- Class
- Class II
- Product code
- FIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970674 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK970674 G.E.M. Water Systems, InternationalG.E.M. Water Systems · 1997
- 1 generation backK992793 Sodium Bicarbonate Mixing/Delivery System, and the Concentrate…Better Water, Inc. · 1999
- This deviceK051031 Ameriwater Solution Mix and Distribution System for HemodialysisAmeriwater · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970674 | G.E.M. Water Systems, International | G.E.M. Water Systems | 1997 | — |
| −1 | K992793 | Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System | Better Water, Inc. | 1999 | — |
| 0 (this device) | K051031 | Ameriwater Solution Mix and Distribution System for Hemodialysis | Ameriwater | 2006 | — |
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 FIN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K992793 | Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery SystemSummary page 1…entral Concentrate Delivery System for Dialysis Central Bicarbonate Mixing/Delivery System (K992793). Page I of 1… | 1999 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FIN devicesFIN Tank, Holding, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FIN
Too few FIN 510(k)s in any year since 2007 to give a median.
Recalls per year · FIN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIN
1in 2018
MAUDE reports naming product code FIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, OOBC100-100, and OOBC100-200 (Dual Tanks): The AmeriWater…
Read the full statement (290 words)
The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications
AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, OOBC100-100, and OOBC100-200 (Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Solution Mixing System, Model OOBC100 (Single Tank): The AmeriWater Solution Mixing System is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Acid Concentrate Distribution System, Models 00AS130, OOAS300, and OOAS500: The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrates necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of use connection for purified water, bicarbonate, and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051031: Ameriwater Solution Mix and Distribution 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/K051031
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