510(k) · Cleared
Recalled · Class II · 2015Granulyte Powder Dialysate Concentrate and Mixing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius USA, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jul 17, 1991 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 17, 1991
- Review
- 105 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK911459 Granulyte Powder Dialysate Concentrate and MixingFresenius USA, Inc. · 1991
- Descendant · cites it directly · 7 of its ownK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- Descendant · 2 generations on · 5 of its ownK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- Descendant · 3 generations on · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
- Descendant · 3 generations on · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK030497 Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX…Fresenius Medical Care · 2003 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K030497 Fresenius Naturalyte Granuflo Dry Acid…cites it directly · 2003
Most influential descendants
Showing 5 of 10 · See all- K980659Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998 · cites it directly7descendants
- K160847Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016 · 2 generations on5descendants
- K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · 3 generations on2descendants
- K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · 3 generations on1descendant
- K030497Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesFresenius Medical Care · 2003 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911459 | Granulyte Powder Dialysate Concentrate and Mixing | Fresenius USA, Inc. | 1991 | — |
| +1 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| +2 | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| +3 | K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018 | 2 |
| +3 | K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023 | 1 |
| +1 | K030497 | Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series… | Fresenius Medical Care | 2003 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 KPO device
- #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2015 | Class II | Z-0294-2016 | Device Design | Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. |
| Nov 20, 2009 | Not classified | Z-2226-2010 | Component design/selection | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K030497Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesFresenius Medical Care · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K980659 (Advanced Renal Technologies, Inc., 1998) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KPO devicesKPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 2025
MAUDE reports naming product code KPO, 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 | 2 | — | 5 | 5 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 107 |
| 2011 | 1 | — | 2 | 223 |
| 2012 | 2 | — | 10 | 70 |
| 2013 | 1 | — | 0 | 3,897 |
| 2014 | 2 | — | 0 | 15,916 |
| 2015 | 1 | — | 3 | 8,340 |
| 2016 | 1 | — | 1 | 240 |
| 2017 | 3 | 192 | 1 | 80 |
| 2018 | 2 | — | 11 | 97 |
| 2019 | 0 | — | 1 | 79 |
| 2020 | 5 | 270 | 31 | 244 |
| 2021 | 1 | — | 0 | 63 |
| 2022 | 2 | — | 2 | 25 |
| 2023 | 3 | 263 | 0 | 59 |
| 2024 | 3 | 112 | 1 | 259 |
| 2025 | 2 | — | 6 | 95 |
| 2026 | 2 | — | 9 | — |
https://510kreport.com/device/K911459 · printed Nov 3, 2026
Cite this page
510(k) Report. “K911459: Granulyte Powder Dialysate Concentrate and Mixing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K911459
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026