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. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Aug 24, 2017 as substantially equivalent to K150472 (Nxstage Medical, Inc., 2015) after a 108-day review. Its family tree reaches back 5 generations to 2010.
- Decided
- Aug 24, 2017
- Review
- 108 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K093069 (2010). No later device cites it as a predicate yet.
- Root · 5 generations backK093069 Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 2010
- 4 generations backK122051 Nxstage System OneNxstage Medical, Inc. · 2013 · Recalled
- 3 generations backK140526 Nxstage System OneNxstage Medical, Inc. · 2014 · Recalled
- 2 generations backK141752 Nxstage System OneNxstage Medical, Inc. · 2014
- 1 generation backK150472 NxStage System OneNxstage Medical, Inc. · 2015
- This deviceK171331 NxStage System OneNxstage Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K093069 | Nxstage System One with Therapeutic Plasma Exchange Cartridge | Nxstage Medical, Inc. | 2010 | — |
| −4 | K122051 | Nxstage System One | Nxstage Medical, Inc. | 2013 | 1 |
| −3 | K140526 | Nxstage System One | Nxstage Medical, Inc. | 2014 | 2 |
| −2 | K141752 | Nxstage System One | Nxstage Medical, Inc. | 2014 | — |
| −1 | K150472 | NxStage System One | Nxstage Medical, Inc. | 2015 | — |
| 0 (this device) | K171331 | NxStage System One | Nxstage Medical, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K150472 | NxStage System OneSummary page 5…technology as the predicate NxStage System One. The NxStage System One has been compared to the legally marketed predicate device as cleared through K150472 (June 04, 2015) and was found to be substantially equivalent. Device Description: The… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2017, 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 System is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.
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 as stated in the FDA summary.
https://510kreport.com/device/K171331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171331: 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/K171331
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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