510(k) · Cleared
Recalled · Class II · 2019Nxstage System One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Jun 24, 2005 as substantially equivalent to K041424 (Nxstage Medical, Inc., 2004) after a 114-day review. Its family tree reaches back 5 generations to 2001. 27 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 24, 2005
- Review
- 114 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001283 (2001). 9 ancestors in all, the oldest K872364 (1987). 27 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 4 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 3 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 2 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 1 generation backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- This deviceK050525 Nxstage System OneNxstage Medical, Inc. · 2005
- Descendant · cites it directly · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- Descendant · 2 generations on · 20 of its ownK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
- Descendant · 2 generations on · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- Descendant · 3 generations on · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- Descendant · 4 generations on · 12 of its ownK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · cites it directly26descendants
- K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009 · 2 generations on20descendants
- K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · 2 generations on16descendants
- K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · 3 generations on13descendants
- K152367Optiflux dialyzerFresenius Medical Care North America · 2015 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −4 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −3 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −2 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −1 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| 0 (this device) | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | — |
| +1 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| +2 | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2009 | — |
| +2 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| +3 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| +4 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 KDI? 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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 |
|---|---|---|---|
| * | K041424 | Nxstage System OneSummary page 1…s: The NxStage System One is substantially equivalent to the following legally marketed predicate device previously cleared by FDA: * NxStage System One, K041424 (cleared on 07/02/04) D. Device Description/indications for Use: The NxStage System One consists of the NxStage Cycler and th… | 2004 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | 2006 | 26 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 27, 2019 | Class II | Z-0697-2020 | Under Investigation by firm | There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing… |
| Jul 27, 2007 | Not classified | Z-1228-2007 | Process change control | Potential for dialysate leaks from the cartridge during treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K062079 (Baxter Healthcare Corporation, 2006) has gone furthest, with 26 descendants of its own.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrafiltration in the home.
All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050525: Nxstage System One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050525
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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