510(k) · Cleared
Recalled · Class I · 2018Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on May 20, 2003 as substantially equivalent to K911459 (Fresenius USA, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1991. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 14 times, including 2 Class I recalls.
- Decided
- May 20, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 14 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911459 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK911459 Granulyte Powder Dialysate Concentrate and MixingFresenius USA, Inc. · 1991 · Recalled
- This deviceK030497 Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX…Fresenius Medical Care · 2003
- Descendant · cites it directly · 0 of its ownK192209 Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911459 | Granulyte Powder Dialysate Concentrate and Mixing | Fresenius USA, Inc. | 1991 | 2 |
| 0 (this device) | K030497 | Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series… | Fresenius Medical Care | 2003 | — |
| +1 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K911459 | Granulyte Powder Dialysate Concentrate and MixingSummary page 1…lysis (liquid or powder) - Class I1 Device Product Code and Panel Code: KPO, 78 Predicate Device(s): Granulyte Powder Dialysate Concentrates and Mixer; (K9 1 1459, SE 07/17/1991); Granulyte Dialysate Concentrate; (K922005, SE 03/30/94) Description: The Fresenius Natural… | 1991 |
| * | K922005 | Granulyte Dialysate ConcentrateSummary page 1…Code: KPO, 78 Predicate Device(s): Granulyte Powder Dialysate Concentrates and Mixer; (K9 1 1459, SE 07/17/1991); Granulyte Dialysate Concentrate; (K922005, SE 03/30/94) Description: The Fresenius NaturalyteO GranufloO Dry Acid Concentrate is designed to be used as direct product rep… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | 2020 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2018 | Class III | Z-0516-2019 | Under Investigation by firm | Discolored powder has confirmed the presence of a foreign substance |
| Oct 9, 2018 | Class III | Z-0518-2019 | Under Investigation by firm | Discolored powder has confirmed the presence of a foreign substance |
| Oct 9, 2018 | Class III | Z-0517-2019 | Under Investigation by firm | Discolored powder has confirmed the presence of a foreign substance |
| Nov 26, 2012 | Class III | Z-0677-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0678-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0681-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0682-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0676-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0679-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0680-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0683-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Nov 26, 2012 | Class III | Z-0684-2013 | Nonconforming Material/Component | GranuFlo Dry Acid Concentrate may show discoloration |
| Mar 29, 2012 | Class I | Z-1827-2012 | Labeling False and Misleading | Risk of Alkalosis with acetate containing dialysis acid concentrates |
| Mar 29, 2012 | Class I | Z-1826-2012 | Labeling False and Misleading | Risk of Alkalosis with acetate containing dialysis acid concentrates |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The Fresenius NaturalyteO GranufloO Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure durjng the hemodialysis procedure. This concentrate is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030497: Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030497
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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