510(k) · Cleared
Recalled · Class II · 2025Modification to: Nxstage Pureflow-B Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Dec 22, 2005 as substantially equivalent to K042045 (Nxstage Medical, Inc., 2004) after a 27-day review. Its family tree reaches back 5 generations to 1987. It has been recalled 14 times.
- Decided
- Dec 22, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 5 generations to K864265 (1987). 9 ancestors in all. 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 backK013448 PrismasateGambro Renal Products · 2002
- 3 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- 2 generations backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- 1 generation backK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
- This deviceK053286 Modification to: Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2005
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 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −3 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| −2 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| −1 | K042045 | Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2004 | 1 |
| 0 (this device) | K053286 | Modification to: Nxstage Pureflow-B Solution | Nxstage Medical, Inc. | 2005 | — |
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? (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 |
|---|---|---|---|
| * | K042045 | Nxstage Pureflow-B SolutionSummary page 2…been compared design specifications. The modified NxStage PureFlow-B Solution has to the baseline as cleared in K042045 and found to be substantially equivalent. Conclusion:… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2025 | Class II | Z-1864-2025 | Under Investigation by firm | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment. |
| May 14, 2024 | Class II | Z-2160-2024 | Under Investigation by firm | The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution… |
| Apr 11, 2019 | Class II | Z-1707-2019 | Labeling mix-ups | Certain lots were mislabeled with incorrect product number. |
| Apr 11, 2019 | Class II | Z-1706-2019 | Labeling mix-ups | Certain lots were mislabeled with incorrect product number. |
| Oct 17, 2018 | Class II | Z-0501-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0507-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0500-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0505-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0506-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0502-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0503-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Oct 17, 2018 | Class II | Z-0504-2019 | Packaging process control | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin |
| Nov 10, 2017 | Class II | Z-1132-2018 | Labeling design | Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during… |
| Jan 24, 2014 | Class II | Z-1073-2014 | Packaging process control | Mislabeled product. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K042045.
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?
The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053286: Modification to: Nxstage Pureflow-B Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053286
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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