510(k) · Cleared
Recalled · Class II · 2018Nxstage Pureflow SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · FKR Subsystem, Proportioning
Cleared on May 15, 2014 as substantially equivalent to K111174 (Nxstage Medical, Inc., 2011) after a 70-day review. Its family tree reaches back 6 generations to 1994. It has been recalled 9 times.
- Decided
- May 15, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- FKR
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921456 (1994). 19 ancestors in all, the oldest K770691 (1977). No later device cites it as a predicate yet.
- Root · 6 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 5 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 4 generations backK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
- 3 generations backK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
- 2 generations backK080919 Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · Recalled
- 1 generation backK111174 Nxstage Pureflow SLNxstage Medical, Inc. · 2011 · Recalled
- This deviceK140571 Nxstage Pureflow SLNxstage Medical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −5 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −4 | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | — |
| −3 | K060296 | Nxstage Dialysate Preparation Module | Nxstage Medical, Inc. | 2006 | — |
| −2 | K080919 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2008 | 1 |
| −1 | K111174 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2011 | 9 |
| 0 (this device) | K140571 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 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 FKR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K111174 | Nxstage Pureflow SLSummary page 3…parison Table - Ptoosed.NxStage PFSL Module Feature N~aeFL ue ~ -(K 111174) 4 (subjet Afhnls-51 0(k))y ____________ Indication for Use… | 2011 |
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 |
|---|---|---|---|---|
| Jan 29, 2018 | Class II | Z-0811-2018 | Material/Component Contamination | May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product. |
| May 14, 2014 | Class II | Z-1854-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1855-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1858-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1857-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1859-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1860-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1856-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| May 14, 2014 | Class II | Z-1861-2014 | Material/Component Contamination | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
The 5 latest of 9 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 20 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 19 ancestors have a recall of any class.
How does its category compare?
All FKR devicesFKR Subsystem, Proportioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FKR
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FKR
Too few FKR 510(k)s in any year since 2007 to give a median.
Recalls per year · FKR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FKR
4in 2025
MAUDE reports naming product code FKR, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140571: Nxstage Pureflow SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140571
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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