510(k) · Cleared
ClearedRockwell Medical CitraPure Acid Concetrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rockwell Medical · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Oct 20, 2016 as substantially equivalent to K980659 (Advanced Renal Technologies, Inc., 1998) and 1 other predicate after a 206-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it.
- Decided
- Oct 20, 2016
- Review
- 206 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864265 (1987). 6 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- 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 deviceK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- Descendant · cites it directly · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
- Descendant · cites it directly · 0 of its ownK180679 CitriCon Liquid and Powder (Acid Concentrate acidified with Citric…Global Scientific Technologies, LLC · 2018
- Descendant · cites it directly · 0 of its ownK171015 CitryteDi-Chem, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · cites it directly2descendants
- K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · cites it directly1descendant
- K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · 2 generations on0descendants
- K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC · 2018 · cites it directly0descendants
- K171015CitryteDi-Chem, Inc. · 2017 · cites it directly0descendants
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) | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| +1 | K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018 | 2 |
| +1 | K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023 | 1 |
| +2 | K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | 2026 | — |
| +1 | K180679 | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid)… | Global Scientific Technologies, LLC | 2018 | — |
| +1 | K171015 | Citryte | Di-Chem, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
Planning a device in KPO? 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…Predicate Device: Primary Predicate Devices: Advanced Renal Technologies (ART) DRYalysate Acid Concentrates K980659 Advanced Renal Technologies (ART) Citrasate Acid Concentrates K000792… | 1998 |
| * | K000792 | Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XXSummary page 4…te Acid Concentrates K980659 Advanced Renal Technologies (ART) Citrasate Acid Concentrates K000792 Reference Predicate Device: Rockwell Medical CitraPure® Acid Concentrates K0… | 2000 |
| † | K062399 | Rockwell Medicaltechnologies, Inc. Citrapure | 2006 |
What descends from it? (5)
4 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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K171750 (Dimesol USA, LLC, 2018) has gone furthest, with 2 descendants of its own.
- 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. 2016, 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?
The Rockwell Medical CitraPure® Acid Concentrates powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
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/K160847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160847: Rockwell Medical CitraPure Acid Concetrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160847
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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