510(k) · Cleared
ClearedB.Braun Premixed Dialysate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Mar 3, 2004 as substantially equivalent to K022913 (Nxstage Medical, Inc., 2002) and 2 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Mar 3, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864265 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 2 generations backK013448 PrismasateGambro Renal Products · 2002
- 1 generation backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- This deviceK034066 B.Braun Premixed DialysateB.Braun Medical, Inc. · 2004
View 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 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −1 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| 0 (this device) | K034066 | B.Braun Premixed Dialysate | B.Braun Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K022913 | Nxstage Premixed DialysateSummary page 2…emtarket Notification B. Braun Premnixed Dialysate SUBSTANTIAL EQUIVALENCE (continued): · NxStage Premixed Dialysate (K022913, cleared 10/21/02) · PrismaSate Dialysis Solutions (KO13448, cleared 01/15/02)… | 2002 |
| * | K013448 | PrismasateSummary page 1…ucts - Gambro PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (K013448) Baxter Healthcare Corporation -Baxter Premixed Dialysate for… | 2002 |
| * | K910270 | Premixed Dialysate for HemodiafiltrationSummary page 1…(K013448) Baxter Healthcare Corporation -Baxter Premixed Dialysate for Liemodiafiltration (K9 10270) DESCRIPTION: The B. Braun Premixed Dialysate Solutions are a family of… | 1991 |
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 17 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K022913.
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 | — |
What is it indicated for?
B. Braun Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034066: B.Braun Premixed Dialysate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034066
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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