510(k) · Cleared
ClearedNxstage System One with Therapeutic Plasma Exchange Cartridge
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 Oct 23, 2010 after a 388-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Oct 23, 2010
- Review
- 388 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK093069 Nxstage System One with Therapeutic Plasma Exchange CartridgeNxstage Medical, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK122051 Nxstage System OneNxstage Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK140526 Nxstage System OneNxstage Medical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK141752 Nxstage System OneNxstage Medical, Inc. · 2014
- Descendant · 4 generations on · 1 of its ownK170469 NxStage System One PlusNxstage Medical, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK150472 NxStage System OneNxstage Medical, Inc. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122051Nxstage System OneNxstage Medical, Inc. · 2013 · cites it directly9descendants
- K140526Nxstage System OneNxstage Medical, Inc. · 2014 · 2 generations on6descendants
- K141752Nxstage System OneNxstage Medical, Inc. · 2014 · 3 generations on5descendants
- K170469NxStage System One PlusNxstage Medical, Inc. · 2017 · 4 generations on1descendant
- K150472NxStage System OneNxstage Medical, Inc. · 2015 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093069 | Nxstage System One with Therapeutic Plasma Exchange Cartridge | Nxstage Medical, Inc. | 2010 | — |
| +1 | K122051 | Nxstage System One | Nxstage Medical, Inc. | 2013 | 1 |
| +2 | K140526 | Nxstage System One | Nxstage Medical, Inc. | 2014 | 2 |
| +3 | K141752 | Nxstage System One | Nxstage Medical, Inc. | 2014 | — |
| +4 | K170469 | NxStage System One Plus | Nxstage Medical, Inc. | 2017 | — |
| +4 | K150472 | NxStage System One | Nxstage Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 112 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?
- Of its descendants, K122051 (Nxstage Medical, Inc., 2013) has gone furthest, with 9 descendants of its own.
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. 2010, 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 indicated for hemodialysis with or without ultrafiltration in the home.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
All treatments must be administered under a 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093069: Nxstage System One with Therapeutic Plasma Exchange Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093069
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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