510(k) · Cleared
Recalled · Class II · 2026Citric Complete Dry Citric Acid (45X)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimesol USA, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Mar 6, 2018 as substantially equivalent to K160847 (Rockwell Medical, 2016) and 2 other predicates after a 266-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 6, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864265 (1987). 15 ancestors in all, the oldest K843963 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 2 generations backK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- 1 generation backK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- This deviceK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −2 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| −1 | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| 0 (this device) | K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K160847 | Rockwell Medical CitraPure Acid ConcetrateSummary page 4…accessories) (4) Product Code: KPO: Gastroenterology/Urology C. Legally Marketed Predicate Devices Rockwell Medical CitraPure® Acid Concentrate (K160847) Diasol, Inc. Citrasol Acid Concentrate (K130511) Dimesol USA, LLC MedicaLyteŒ Bicarbonate Powder (K131202) ______… | 2016 |
| * | K130511 | Citrisol Acid ConcentrateSummary page 4…terology/Urology C. Legally Marketed Predicate Devices Rockwell Medical CitraPure® Acid Concentrate (K160847) Diasol, Inc. Citrasol Acid Concentrate (K130511) Dimesol USA, LLC MedicaLyteŒ Bicarbonate Powder (K131202) ________________________________________ 510(k) Premarket Noti… | 2014 |
| * | K131202 | Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X)…Summary page 4…Rockwell Medical CitraPure® Acid Concentrate (K160847) Diasol, Inc. Citrasol Acid Concentrate (K130511) Dimesol USA, LLC MedicaLyteŒ Bicarbonate Powder (K131202) ________________________________________ 510(k) Premarket Notification for Dimesol USA, LLC K171750 Citric CompleteŒ Dry Citric… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223431 | Citric Complete Liquid Citric Acid Concentrate | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2026 | Class II | Z-3135-2026 | Process control | Hemodialysis concentrates contain high endotoxin levels |
| Nov 22, 2024 | Class II | Z-0820-2025 | Process control | The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K223431 (Nipro Renal Solutions USA, Corp., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K160847.
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. 2018, 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?
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyte™ bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as Medicalyte Bicarbonate™, in a 45x three-stream artificial kidney (hemodialysis) machine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171750: Citric Complete Dry Citric Acid (45X).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171750
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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