510(k) · Cleared
Recalled · Class II · 2026pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on May 10, 2024 as substantially equivalent to K233159 (Fresenius Medical Care Renal Therapies Group, LLC, 2023) after a 148-day review. Its family tree reaches back 9 generations to 1987. 2 later devices descend from it. It has been recalled once.
- Decided
- May 10, 2024
- Review
- 148 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K864265 (1987). 15 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 5 generations between
- 3 generations backK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
- 2 generations backK162887 PrismaSATEBaxter Healthcare Corporation · 2017
- 1 generation backK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- This deviceK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024
- Descendant · cites it directly · 1 of its ownK243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK252180 Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Show all 9 generations
- Root · 9 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 8 generations backK013448 PrismasateGambro Renal Products · 2002
- 7 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- 6 generations backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- 5 generations backK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
- 4 generations backK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · Recalled
- 3 generations backK120333 Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
- 2 generations backK162887 PrismaSATEBaxter Healthcare Corporation · 2017
- 1 generation backK233159 pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- This deviceK233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401…Fresenius Medical Care Renal Therapies Group, LLC · 2024
Most influential descendants
Showing 2 of 2 · See all- K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · cites it directly1descendant
- K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −8 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −7 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| −6 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| −5 | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | 1 |
| −4 | K072908 | Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy | Gambro Renal Products | 2008 | 1 |
| −3 | K120333 | Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy | Gambro Renal Products | 2012 | — |
| −2 | K162887 | PrismaSATE | Baxter Healthcare Corporation | 2017 | — |
| −1 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
| 0 (this device) | K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069)… | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
| +1 | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G)… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | 2 |
| +2 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W)… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
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 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Summary page 5…edicate device for the proposed pureFLOW dialysis solutions manufactured in Guadalajara, Mexico is the pureFLOW dialysis solutions manufactured from St. Wendel, Germany (K233159). This device is not currently subject to a design-related recall. 1.4. Device Description 1.4.1. Device Identificat… | 2023 |
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 |
|---|---|---|---|
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby… | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-2321-2026 | Process design | Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K243786 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K233159.
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. 2024, 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?
pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233950: pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233950
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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