510(k) · Cleared
Recalled · Class II · 2026Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on May 8, 2020 as substantially equivalent to K980659 (Advanced Renal Technologies, Inc., 1998) and 1 other predicate after a 268-day review. Its family tree reaches back 2 generations to 1987. 1 of the 7 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- May 8, 2020
- Review
- 268 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864265 (1987). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 1 generation backK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- This deviceK192209 Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020
Class I recalls in this family
- K030497 Fresenius Naturalyte Granuflo Dry Acid…direct predicate · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −1 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| 0 (this device) | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 1 |
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 |
|---|---|---|---|
| * | K980659 | Dryalysate ConcentrateSummary page 4…y 5.3. Legally Marketed Predicate Device The legally marketed predicate device for the Citrasate Dry Acid Concentrate is the DRYalysate Concentrate cleared under K980659. The legally marketed predicate device for the GranuFlo Dry Acid Concentrate is the Naturalyte Granuflo Dry Acid Concentrate clea… | 1998 |
| * | K030497 | Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesSummary page 4…centrate cleared under K980659. The legally marketed predicate device for the GranuFlo Dry Acid Concentrate is the Naturalyte Granuflo Dry Acid Concentrate cleared under K030497. GranuFlo Dry Acid Concentrate is currently subject to an open recall (Z-0516-2019, Z-0517- 2019, and Z-0518-2019). Destruction o… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2026 | Class II | Z-3091-2026 | Material/Component Contamination | Complaints of blue-green discoloration in product |
| Apr 28, 2021 | Class II | Z-2084-2021 | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions |
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 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 21.9 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K980659.
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. 2020, this device’s year, is highlighted.
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?
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician’s prescription.
GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician’s prescription.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192209: Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192209
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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