510(k) · Cleared
ClearedNxstage System One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · ODN Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Cleared on Dec 19, 2014 as substantially equivalent to K140526 (Nxstage Medical, Inc., 2014) after a 172-day review. Its family tree reaches back 3 generations to 2010. 5 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 172 days
- Class
- Class II
- Product code
- ODN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K093069 (2010). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK093069 Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 2010
- 2 generations backK122051 Nxstage System OneNxstage Medical, Inc. · 2013 · Recalled
- 1 generation backK140526 Nxstage System OneNxstage Medical, Inc. · 2014 · Recalled
- This deviceK141752 Nxstage System OneNxstage Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK170469 NxStage System One PlusNxstage Medical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK150472 NxStage System OneNxstage Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK233557 HemoCare Hemodialysis SystemDeka Research and Development · 2024
- Descendant · 2 generations on · 0 of its ownK230632 VersiHD with GuideMe softwareNxstage Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK171331 NxStage System OneNxstage Medical, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K170469NxStage System One PlusNxstage Medical, Inc. · 2017 · cites it directly1descendant
- K150472NxStage System OneNxstage Medical, Inc. · 2015 · cites it directly1descendant
- K233557HemoCare Hemodialysis SystemDeka Research and Development · 2024 · cites it directly0descendants
- K230632VersiHD with GuideMe softwareNxstage Medical, Inc. · 2023 · 2 generations on0descendants
- K171331NxStage System OneNxstage Medical, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K093069 | Nxstage System One with Therapeutic Plasma Exchange Cartridge | Nxstage Medical, Inc. | 2010 | — |
| −2 | K122051 | Nxstage System One | Nxstage Medical, Inc. | 2013 | 1 |
| −1 | K140526 | Nxstage System One | Nxstage Medical, Inc. | 2014 | 2 |
| 0 (this device) | K141752 | Nxstage System One | Nxstage Medical, Inc. | 2014 | — |
| +1 | K170469 | NxStage System One Plus | Nxstage Medical, Inc. | 2017 | — |
| +1 | K150472 | NxStage System One | Nxstage Medical, Inc. | 2015 | — |
| +1 | K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024 | — |
| +2 | K230632 | VersiHD with GuideMe software | Nxstage Medical, Inc. | 2023 | — |
| +2 | K171331 | NxStage System One | Nxstage Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 ODN? 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 |
|---|---|---|---|
| * | K140526 | Nxstage System OneSummary page 5…he same fundamental technology as the predicate NxStage System One. The NxStage System One has been compared to the legally marketed predicate device as cleared through K140526 (May 19, 2014) and was found to be substantially equivalent. E. Device Description/Indications for Use: The NxStage System One i… | 2014 |
What descends from it? (5)
3 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 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K170469 (Nxstage Medical, Inc., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ODN devicesODN Ultrafiltration-Controlled Nocturnal Dialysate Delivery System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · ODN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · ODN
Too few ODN 510(k)s in any year since 2007 to give a median.
Recalls per year · ODN
No recall names ODN since 2007.
Adverse event reports per year · ODN
No MAUDE report names ODN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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 home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician’s prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141752: 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/K141752
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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