510(k) · Cleared
ClearedDry AC Acid Concentrate Mix for Bicarbonate Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Aug 2, 2001 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it.
- Decided
- Aug 2, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK011368 Dry AC Acid Concentrate Mix for Bicarbonate HemodialysisGambro Renal Products · 2001
- Descendant · cites it directly · 18 of its ownK013448 PrismasateGambro Renal Products · 2002
- Descendant · 2 generations on · 12 of its ownK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- Descendant · 3 generations on · 10 of its ownK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- Descendant · 4 generations on · 8 of its ownK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK041683 B. Braun Bicarbonate DialysateB.Braun Medical, Inc. · 2004
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K013448PrismasateGambro Renal Products · 2002 · cites it directly18descendants
- K022913Nxstage Premixed DialysateNxstage Medical, Inc. · 2002 · 2 generations on12descendants
- K033386Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003 · 3 generations on10descendants
- K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · 4 generations on8descendants
- K041683B. Braun Bicarbonate DialysateB.Braun Medical, Inc. · 2004 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011368 | Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis | Gambro Renal Products | 2001 | — |
| +1 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| +2 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| +3 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| +4 | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | 1 |
| +2 | K041683 | B. Braun Bicarbonate Dialysate | B.Braun Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (20)
See all 202 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?
- Of its descendants, K013448 (Gambro Renal Products, 2002) has gone furthest, with 18 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K011368 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011368: Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011368
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026