510(k) · Cleared
ClearedNxstage 1.6M2 Dialyzer
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 Dec 27, 2013 as substantially equivalent to K061837 (Nxstage Medical, Inc., 2006) and 2 other predicates after a 256-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Dec 27, 2013
- Review
- 256 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001283 (2001). 24 ancestors in all, the oldest K872364 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 6 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 5 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 4 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 3 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 2 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 1 generation backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- This deviceK131050 Nxstage 1.6M2 DialyzerNxstage Medical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −6 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −5 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −4 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −3 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −2 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| −1 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| 0 (this device) | K131050 | Nxstage 1.6M2 Dialyzer | Nxstage Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K061837 | Nxstage Cartridge ExpressSummary page 2…11 Device Panel: Gastroenterology-Urology (GU)I Gastro-Renal (GROB) D. Predicate Devices: K061837 NxStage Cartridge Express K1 13023 NxStage Streamline Airless System Set w/ Pre-Attached Dialyzer K<062079 Baxter Xenium Di… | 2006 |
| * | K113023 | Streamline Airless System Set with Pre-Attached DialyzerSummary page 2…Gastroenterology-Urology (GU)I Gastro-Renal (GROB) D. Predicate Devices: K061837 NxStage Cartridge Express K1 13023 NxStage Streamline Airless System Set w/ Pre-Attached Dialyzer K<062079 Baxter Xenium Dialyzer E. Substantial Equivalence:… | 2012 |
| * | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Summary page 4…Dialyzer Cartridge Pre-attched Dlalyzer 150 Express dialyzer (K062079) (1(061837) (K(113023) Connectors Standard Blood and… | 2006 |
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 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 24 ancestors have a recall of any class.
- 3 other devices also cite its predicate K061837.
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 dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemoflltration, hemodialysis. and/or ultrafiltration. There are no known contraindications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131050: Nxstage 1.6M2 Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131050
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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