510(k) · Cleared
Recalled · Class II · 2015Nxstage System One with Nxview
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 Mar 3, 2014 as substantially equivalent to K122051 (Nxstage Medical, Inc., 2013) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 3, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921456 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK921456 Fresenius 3008/FDS-08 Dialysate Delivery SystemFresenius USA, Inc. · 1994 · Recalled
- 1 generation backK040074 Oneview InterfaceNxstage Medical, Inc. · 2004
- This deviceK133547 Nxstage System One with NxviewNxstage Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK252377 NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026 · 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 | K040074 | Oneview Interface | Nxstage Medical, Inc. | 2004 | — |
| 0 (this device) | K133547 | Nxstage System One with Nxview | Nxstage Medical, Inc. | 2014 | — |
| +1 | K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (2)
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…amental technology as the predicate NxStage System One. The NxStage System One with NxView has been compared to the legally marketed predicate devices as cleared through K122051 (April 23, 2013) and K040074 (April 8, 2004) and was found to be substantially equivalent. E. Device Description/Indications for… | 2013 |
| * | K040074 | Oneview InterfaceSummary page 2…dicate NxStage System One. The NxStage System One with NxView has been compared to the legally marketed predicate devices as cleared through K122051 (April 23, 2013) and K040074 (April 8, 2004) and was found to be substantially equivalent. E. Device Description/Indications for Use: The NxStage System One… | 2004 |
| † | K043436 | Nxstage Dialysate Preparation Module, Model NX0269 | 2005 |
| † | K060236 | MW-1000 Iontophoretic Drug Delivery Electrode | 2006 |
| † | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | 2002 |
| † | K111174 | Nxstage Pureflow SL | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252377 | NxStage System One with NxView | 2026 | 0 |
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-0326-2016 | Software Design Change | Ultrafiltration (UF) Volume software error inaccurate fluid removal |
| Oct 29, 2015 | Class II | Z-0327-2016 | Software Design Change | Ultrafiltration (UF) Volume software error inaccurate fluid removal |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K252377 (Fresenius Medical Care Renal Therapies Group, LLC, 2026) has gone furthest, with 0 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?
NxStage System One: 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 Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person…
Read the full statement (114 words)
NxStage System One:
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 Therapeutic Plasma Exchange in a clinical environment.
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.
NxView:
NxView is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access.
NxView is contraindicated as the sole method of monitoring a patient during treatment.
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/K133547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133547: Nxstage System One with Nxview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133547
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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