510(k) · Cleared
ClearedNxStage PureFlow 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 Jan 18, 2024 as substantially equivalent to K033386 (Nxstage Medical, Inc., 2003) after a 112-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jan 18, 2024
- Review
- 112 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864265 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 3 generations backK013448 PrismasateGambro Renal Products · 2002
- 2 generations backK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
- 1 generation backK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
- This deviceK233213 NxStage PureFlow SolutionNxstage Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −3 | K013448 | Prismasate | Gambro Renal Products | 2002 | — |
| −2 | K022913 | Nxstage Premixed Dialysate | Nxstage Medical, Inc. | 2002 | — |
| −1 | K033386 | Nxstage Pureflow Solution | Nxstage Medical, Inc. | 2003 | — |
| 0 (this device) | K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K033386 | Nxstage Pureflow SolutionSummary page 5…5.3. Legally Marketed Predicate Device The legally marketed predicate for the proposed device is the NxStage PureFlow Solution, as cleared through K033386 (November 26, 2003). This predicate has not been subject to a design-related recall. 5.4. Device Description… | 2003 |
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 37 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K033386.
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?
NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233213: NxStage PureFlow Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233213
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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