510(k) · Cleared
Recalled · Class II · 2014Nxstage 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 Sep 19, 2011 as substantially equivalent to K080919 (Nxstage Medical, Inc., 2008) after a 145-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Sep 19, 2011
- Review
- 145 days
- Class
- Class II
- Product code
- FKR
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921456 (1994). 18 ancestors in all, the oldest K770691 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 4 generations backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- 3 generations backK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
- 2 generations backK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
- 1 generation backK080919 Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · Recalled
- This deviceK111174 Nxstage Pureflow SLNxstage Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK140571 Nxstage Pureflow SLNxstage Medical, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140571Nxstage Pureflow SLNxstage Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −4 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| −3 | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | — |
| −2 | K060296 | Nxstage Dialysate Preparation Module | Nxstage Medical, Inc. | 2006 | — |
| −1 | K080919 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2008 | 1 |
| 0 (this device) | K111174 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2011 | — |
| +1 | K140571 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2014 | 9 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K080919 | Nxstage Pureflow SLSummary page 2…96-hours meets design specifications. The NxStage PFSL module with modifications has been compared to the legally marketed PFSL predicate device as cleared through K080919 (October 15, 2058) and was found to be substantially equivalent. D. Device Descriptionlindications for Use: The NxStage PF… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140571 | Nxstage Pureflow SL | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 |
| Dec 14, 2011 | Not classified | Z-0826-2012 | Employee error | Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System |
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 17 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K140571 (Nxstage Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FKR devicesFKR Subsystem, Proportioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 OneTM 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/K111174 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111174: Nxstage Pureflow SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111174
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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