510(k) · Cleared
Recalled · Class II · 2015Nxstage 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 May 19, 2014 as substantially equivalent to K122051 (Nxstage Medical, Inc., 2013) after a 76-day review. Its family tree reaches back 2 generations to 2010. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- May 19, 2014
- Review
- 76 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093069 (2010). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK093069 Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 2010
- 1 generation backK122051 Nxstage System OneNxstage Medical, Inc. · 2013 · Recalled
- This deviceK140526 Nxstage System OneNxstage Medical, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK141752 Nxstage System OneNxstage Medical, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK170469 NxStage System One PlusNxstage Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK150472 NxStage System OneNxstage Medical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
- Descendant · 3 generations on · 0 of its ownK230632 VersiHD with GuideMe softwareNxstage Medical, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141752Nxstage System OneNxstage Medical, Inc. · 2014 · cites it directly5descendants
- K170469NxStage System One PlusNxstage Medical, Inc. · 2017 · 2 generations on1descendant
- K150472NxStage System OneNxstage Medical, Inc. · 2015 · 2 generations on1descendant
- K233557HemoCare Hemodialysis SystemDeka Research and Development · 2024 · 2 generations on0descendants
- K230632VersiHD with GuideMe softwareNxstage Medical, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093069 | Nxstage System One with Therapeutic Plasma Exchange Cartridge | Nxstage Medical, Inc. | 2010 | — |
| −1 | K122051 | Nxstage System One | Nxstage Medical, Inc. | 2013 | 1 |
| 0 (this device) | K140526 | Nxstage System One | Nxstage Medical, Inc. | 2014 | — |
| +1 | K141752 | Nxstage System One | Nxstage Medical, Inc. | 2014 | — |
| +2 | K170469 | NxStage System One Plus | Nxstage Medical, Inc. | 2017 | — |
| +2 | K150472 | NxStage System One | Nxstage Medical, Inc. | 2015 | — |
| +2 | K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024 | — |
| +3 | K230632 | VersiHD with GuideMe software | Nxstage Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K122051 | Nxstage System OneSummary page 2…fundamental technology as the predicate NxStage System One. The NxStage System One has been compared to the legally marketed predicate devices as cleared through K122051 (April 23. 2013) and was found to be substantially equivalent. E.Device Description/indications for Use: The NxStage Sys… | 2013 |
| † | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | 2005 |
| † | K060296 | Nxstage Dialysate Preparation Module | 2006 |
| † | K090919 | Kensey Nash Fibrillar Collagen Dental Membrane | 2009 |
| † | K111174 | Nxstage Pureflow SL | 2011 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141752 | Nxstage System One | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2015 | Class II | Z-0336-2016 | Software design | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed |
| Oct 29, 2015 | Class II | Z-0337-2016 | Software design | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed |
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 2.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K141752 (Nxstage Medical, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K122051.
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. 2014, this device’s year, is highlighted.
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 NxStage System One 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/K140526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140526: 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/K140526
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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