510(k) · Cleared
Recalled · Class II · 2026Citric Complete Liquid Citric Acid Concentrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Renal Solutions USA, Corp. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Aug 4, 2023 as substantially equivalent to K160847 (Rockwell Medical, 2016) and 3 other predicates after a 263-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 4, 2023
- Review
- 263 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K864265 (1987). 16 ancestors in all, the oldest K843963 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 3 generations backK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- 2 generations backK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- 1 generation backK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
- This deviceK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023
- Descendant · cites it directly · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
Most influential descendants
Showing 1 of 1 · See all- K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −3 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| −2 | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| −1 | K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018 | 2 |
| 0 (this device) | K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (4)
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…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K160847 I CitraPure@ Acid Concentrate IKPO I K130511… | 2016 |
| * | K130511 | Citrisol Acid ConcentrateSummary page 4…) Product Code I K160847 I CitraPure@ Acid Concentrate IKPO I K130511 I CitriSol Acid Concentrate IKPO I K901471… | 2014 |
| * | K901471 | GC-1000 Through GC-3005 Acid ConcentrateSummary page 4…IKPO I K130511 I CitriSol Acid Concentrate IKPO I K901471 GC-1000 to GC-3005 Acid Concentrate (MedicaPureT r Liquid AI KPO I K171750 Citric Comp… | 1990 |
| * | K171750 | Citric Complete Dry Citric Acid (45X)Summary page 4…trate IKPO I K901471 GC-1000 to GC-3005 Acid Concentrate (MedicaPureT r Liquid AI KPO I K171750 Citric Complete TM Dry Citric Acid Concentrate IKPO I Device Descrip… | 2018 |
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 |
|---|---|---|---|
| K260799 | Nipro Dry Acid Concentrate Mixer | 2026 | 0 |
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-3136-2026 | Process control | Hemodialysis concentrates contain high endotoxin levels |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 11.2 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K260799 (Nipro Technical Solutions, Incoporated, 2026) has gone furthest, with 0 descendants 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. 2023, 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?
For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine.
For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223431 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223431: Citric Complete Liquid Citric Acid Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223431
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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