510(k) · Cleared
ClearedModification to: Lifemate Hemofiltration System
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 19, 2001 as substantially equivalent to K001283 (Nxstage Medical, Inc., 2001) after a 74-day review. Its family tree reaches back 1 generation to 2001. 33 later devices descend from it.
- Decided
- Oct 19, 2001
- Review
- 74 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001283 (2001). 33 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- This deviceK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- Descendant · cites it directly · 32 of its ownK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- Descendant · 2 generations on · 29 of its ownK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- Descendant · 3 generations on · 28 of its ownK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- Descendant · 4 generations on · 27 of its ownK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- Descendant · 5 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K020858Nxstage Therapy SystemNxstage Medical, Inc. · 2002 · cites it directly32descendants
- K030470Nxstage System OneNxstage Medical, Inc. · 2003 · 2 generations on29descendants
- K041424Nxstage System OneNxstage Medical, Inc. · 2004 · 3 generations on28descendants
- K050525Nxstage System OneNxstage Medical, Inc. · 2005 · 4 generations on27descendants
- K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| 0 (this device) | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| +1 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| +2 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| +3 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| +4 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| +5 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K001283 | Lifemate Hemofiltration SystemSummary page 2…has been performed to ensure that the modified device meets design specifications. The modified LifeMate™ System has been compared to the LifeMate™ System as cleared in K001283. Conclusion: Based on the device indications for use, comparison of descriptive and technological characteristics, and design c… | 2001 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020858 | Nxstage Therapy System | 2002 | 32 |
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?
- Its one ancestor has no recall.
- Of its descendants, K020858 (Nxstage Medical, Inc., 2002) has gone furthest, with 32 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.
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 LifeMate™ Hemofiltration System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
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/K012510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012510: Modification to: Lifemate Hemofiltration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012510
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026