510(k) · Cleared
ClearedNipro Dry Acid Concentrate Mixer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Technical Solutions, Incoporated · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Aug 19, 2026 as substantially equivalent to K983618 (Rockwell Medical Technologies, Inc., 1999) and 2 other predicates after a 161-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Aug 19, 2026
- Review
- 161 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K864265 (1987). 21 ancestors in all, the oldest K843963 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 4 generations backK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- 3 generations backK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- 2 generations backK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
- 1 generation backK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
- This deviceK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −4 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| −3 | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| −2 | 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 |
| 0 (this device) | 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 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K983618 | Dri-Sate Mixer for Preparation of Acidified Dialysate ConcentrateSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K983618 Dri-Sate Mixer for Preparation of Acidified Dialysate Concentrate KPO K191093 Isopure Dry… | 1999 |
| * | K191093 | Isopure Dry Acid Dissolution SystemSummary page 5…Name (Primary Predicate is listed first) Product Code K983618 Dri-Sate Mixer for Preparation of Acidified Dialysate Concentrate KPO K191093 Isopure Dry Acid Dissolution System KPO K223431 Nipro Citric… | 2020 |
| * | K223431 | Citric Complete Liquid Citric Acid ConcentrateSummary page 5…i-Sate Mixer for Preparation of Acidified Dialysate Concentrate KPO K191093 Isopure Dry Acid Dissolution System KPO K223431 Nipro Citric Complete Liquid Citric Acid Concentrate KPO Device Description Summary… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- 7 of the 21 ancestors have a recall of any class.
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. 2026, 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 Nipro Dry Acid Concentrate Mixer is intended for the mixing of dry acid concentrate with treated water that meets the requirements of ISO 23500-3, “Preparation and quality management of fluids for hemodialysis and related therapies—Part 3: Water for hemodialysis and related therapies” to produce an acid concentrate solution intended for use in hemodialysis treatment and related therapies, using a 3-stream dialysate (acid concentrate, bicarbonate concentrate, and water).
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/K260799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260799: Nipro Dry Acid Concentrate Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260799
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026