510(k) · Cleared
ClearedNxstage Dialysate Preparation Module, Model NX0269
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 Mar 17, 2005 as substantially equivalent to K010131 (Aksys, Ltd., 2002) and 2 other predicates after a 94-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- Mar 17, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- FKR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K921456 (1994). 15 ancestors in all, the oldest K770691 (1977). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 1 generation backK994267 Fresenius 2008KFresenius Medical Care · 2000 · Recalled
- This deviceK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK080919 Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK111174 Nxstage Pureflow SLNxstage Medical, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 0 of its ownK140571 Nxstage Pureflow SLNxstage Medical, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK081043 Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · cites it directly3descendants
- K080919Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · 2 generations on2descendants
- K111174Nxstage Pureflow SLNxstage Medical, Inc. · 2011 · 3 generations on1descendant
- K140571Nxstage Pureflow SLNxstage Medical, Inc. · 2014 · 4 generations on0descendants
- K081043Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921456 | Fresenius 3008/FDS-08 Dialysate Delivery System | Fresenius USA, Inc. | 1994 | 3 |
| −1 | K994267 | Fresenius 2008K | Fresenius Medical Care | 2000 | 5 |
| 0 (this device) | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | Nxstage Medical, Inc. | 2005 | — |
| +1 | K060296 | Nxstage Dialysate Preparation Module | Nxstage Medical, Inc. | 2006 | — |
| +2 | K080919 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2008 | 1 |
| +3 | K111174 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2011 | 9 |
| +4 | K140571 | Nxstage Pureflow SL | Nxstage Medical, Inc. | 2014 | 9 |
| +1 | K081043 | Leak Detection Sensor and Tray Accessory Kit | Nxstage Medical, Inc. | 2008 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K010131 | PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Summary page 1…e NxStage Dialysate Prep Module is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA: • Aksys PHD System, K010131 (cleared on 03/26/02) • Fresenius 2008K Hemodialysis System, K994267 (cleared on 03/16/00) • Gambro Bicarbonate Mod… | 2002 |
| * | K994267 | Fresenius 2008KSummary page 1…legally marketed predicate devices previously cleared by FDA: • Aksys PHD System, K010131 (cleared on 03/26/02) • Fresenius 2008K Hemodialysis System, K994267 (cleared on 03/16/00) • Gambro Bicarbonate Module BCM-10, K810127 (cleared on 02/25/81) Traditional 510(k) Confidentia… | 2000 |
| * | K810127 | Gambro Bicarbonate Module, BCM-10Summary page 1…Aksys PHD System, K010131 (cleared on 03/26/02) • Fresenius 2008K Hemodialysis System, K994267 (cleared on 03/16/00) • Gambro Bicarbonate Module BCM-10, K810127 (cleared on 02/25/81) Traditional 510(k) Confidential… | 1981 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K060296 (Nxstage Medical, Inc., 2006) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K010131.
How does its category compare?
All FKR devicesFKR Subsystem, Proportioning: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Dialysate Preparation 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/K043436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043436: Nxstage Dialysate Preparation Module, Model NX0269.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043436
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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