510(k) · Cleared
ClearedG.E.M. Water Systems, International
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.E.M. Water Systems · FIN Tank, Holding, Dialysis
Cleared on Nov 19, 1997 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Nov 19, 1997
- Review
- 268 days
- Class
- Class II
- Product code
- FIN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK970674 G.E.M. Water Systems, InternationalG.E.M. Water Systems · 1997
- Descendant · cites it directly · 1 of its ownK992793 Sodium Bicarbonate Mixing/Delivery System, and the Concentrate…Better Water, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK051031 Ameriwater Solution Mix and Distribution System for HemodialysisAmeriwater · 2006
- Descendant · cites it directly · 0 of its ownK030366 Bicard Mixing SystemDialysis Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK023011 Osmonics Solution Delivery SystemOsmonics Medical Systems · 2003
Most influential descendants
Showing 4 of 4 · See all- K992793Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery SystemBetter Water, Inc. · 1999 · cites it directly1descendant
- K051031Ameriwater Solution Mix and Distribution System for HemodialysisAmeriwater · 2006 · 2 generations on0descendants
- K030366Bicard Mixing SystemDialysis Systems, Inc. · 2004 · cites it directly0descendants
- K023011Osmonics Solution Delivery SystemOsmonics Medical Systems · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K051031 | Ameriwater Solution Mix and Distribution System for Hemodialysis | Ameriwater | 2006 | — |
| +1 | K030366 | Bicard Mixing System | Dialysis Systems, Inc. | 2004 | — |
| +1 | K023011 | Osmonics Solution Delivery System | Osmonics Medical Systems | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 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?
- Of its descendants, K992793 (Better Water, Inc., 1999) has gone furthest, with 1 descendant of its own.
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 INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI| STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970674: G.E.M. Water Systems, International.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970674
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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