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 Apr 23, 2013 as substantially equivalent to K093069 (Nxstage Medical, Inc., 2010) after a 285-day review. Its family tree reaches back 1 generation to 2010. 9 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 2013
- Review
- 285 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093069 (2010). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK093069 Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 2010
- This deviceK122051 Nxstage System OneNxstage Medical, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK140526 Nxstage System OneNxstage Medical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK141752 Nxstage System OneNxstage Medical, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK170469 NxStage System One PlusNxstage Medical, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK150472 NxStage System OneNxstage Medical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK133547 Nxstage System One with NxviewNxstage Medical, Inc. · 2014 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K140526Nxstage System OneNxstage Medical, Inc. · 2014 · cites it directly6descendants
- K141752Nxstage System OneNxstage Medical, Inc. · 2014 · 2 generations on5descendants
- K170469NxStage System One PlusNxstage Medical, Inc. · 2017 · 3 generations on1descendant
- K150472NxStage System OneNxstage Medical, Inc. · 2015 · 3 generations on1descendant
- K133547Nxstage System One with NxviewNxstage Medical, Inc. · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093069 | Nxstage System One with Therapeutic Plasma Exchange Cartridge | Nxstage Medical, Inc. | 2010 | — |
| 0 (this device) | K122051 | Nxstage System One | Nxstage Medical, Inc. | 2013 | — |
| +1 | K140526 | Nxstage System One | Nxstage Medical, Inc. | 2014 | 2 |
| +2 | K141752 | Nxstage System One | Nxstage Medical, Inc. | 2014 | — |
| +3 | K170469 | NxStage System One Plus | Nxstage Medical, Inc. | 2017 | — |
| +3 | K150472 | NxStage System One | Nxstage Medical, Inc. | 2015 | — |
| +1 | K133547 | Nxstage System One with Nxview | Nxstage Medical, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K093069 | Nxstage System One with Therapeutic Plasma Exchange Cartridge | 2010 |
What descends from it? (9)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2015 | Class II | Z-0335-2016 | 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?
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. 2013, 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 hemorfiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrfltration in the home.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122051: 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/K122051
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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