510(k) · Cleared
ClearedXenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation - Renal Division · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Feb 17, 2010 as substantially equivalent to K083778 (Baxter Healthcare Corporation, 2009) after a 138-day review. Its family tree reaches back 8 generations to 2001. 6 later devices descend from it.
- Decided
- Feb 17, 2010
- Review
- 138 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001283 (2001). 16 ancestors in all, the oldest K872364 (1987). 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 7 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 6 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 5 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 4 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 3 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 2 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- 1 generation backK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
- This deviceK093120 Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM…Baxter Healthcare Corporation - Renal Division · 2010
- Descendant · cites it directly · 5 of its ownK122347 Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation · 2013
- Descendant · 2 generations on · 3 of its ownK131935 Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation · 2013
- Descendant · 2 generations on · 2 of its ownK131381 Elisio-H HemodialyzerNipro Medical Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK140191 Elisio-H HemodialyzerNipro Medical Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK260533 Elisio™-HNipro Medical Corporation · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122347Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation · 2013 · cites it directly5descendants
- K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation · 2013 · 2 generations on3descendants
- K131381Elisio-H HemodialyzerNipro Medical Corporation · 2013 · 2 generations on2descendants
- K140191Elisio-H HemodialyzerNipro Medical Corporation · 2014 · 3 generations on1descendant
- K260533Elisio™-HNipro Medical Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −7 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −6 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −5 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −4 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −3 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| −2 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| −1 | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2009 | — |
| 0 (this device) | K093120 | Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150… | Baxter Healthcare Corporation - Renal Division | 2010 | — |
| +1 | K122347 | Elisio-H and Elisio-M Hemodialyzers | Nipro Medical Corporation | 2013 | — |
| +2 | K131935 | Elisio-H Hemodialyzer, Elisio-M Hemodialyzer | Nipro Medical Corporation | 2013 | — |
| +2 | K131381 | Elisio-H Hemodialyzer | Nipro Medical Corporation | 2013 | — |
| +3 | K140191 | Elisio-H Hemodialyzer | Nipro Medical Corporation | 2014 | — |
| +3 | K260533 | Elisio™-H | Nipro Medical Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210Summary page 2…____ ~~Device Cmay Previous&51O(k)- - Clearance-date.~- Xeniumn XPH Baxter K083778 Februrary 20, Healthcare 2009… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122347 | Elisio-H and Elisio-M Hemodialyzers | 2013 | 5 |
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 9 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K122347 (Nipro Medical Corporation, 2013) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K083778.
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?
Hemodialysis with Xenium XPM dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
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/K093120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093120: Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093120
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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