510(k) · Cleared
ClearedmultiFlux 130 (F00013123); multiFlux 160 (F00013124)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Feb 10, 2026 as substantially equivalent to K240394 (Fresenius Medical Care Renal Therapies Group, LLC, 2024) after a 189-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Feb 10, 2026
- Review
- 189 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K001283 (2001). 36 ancestors in all, the oldest K872364 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 9 generations between
- 3 generations backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- 2 generations backK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- 1 generation backK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024
- This deviceK252459 multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026
Show all 13 generations
- Root · 13 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 12 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 11 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 10 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 9 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 8 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 7 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- 6 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- 5 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- 4 generations backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- 3 generations backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- 2 generations backK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- 1 generation backK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024
- This deviceK252459 multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −12 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −11 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −10 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −9 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −8 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| −7 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| −6 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| −5 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| −4 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
| −3 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 4 |
| −2 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL… | Fresenius Medical Care Renal Therapies Group, LLC | 2023 | — |
| −1 | K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
| 0 (this device) | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240394 | multiFlux 1000 (F00012408)Summary page 5…Marketed Predicate Device The legally marketed primary predicate device for the proposed multiFlux 130 and 160 hemofilters is the multiFlux 1000 hemofilter cleared under K240394. The FX CorAL dialyzers cleared under K243784 are being used as a secondary predicate to support the labeling modifications. The… | 2024 |
| Kept off the family tree | K243784 | FDA’s K243784 is Stryker Orthopaedics Hip Devices Labeling Update Our reading of the summary gave K243784, FDA’s number for Stryker Orthopaedics Hip Devices Labeling Update (Howmedica Osteonics Corp., Dba Stryker Orthopaedics). Its FDA name has none of the distinctive words the summary uses for the device it names, “FX CorAL dialyzers”. Kept off the family tree. Summary page 5…primary predicate device for the proposed multiFlux 130 and 160 hemofilters is the multiFlux 1000 hemofilter cleared under K240394. The FX CorAL dialyzers cleared under K243784 are being used as a secondary predicate to support the labeling modifications. The FX CorAL 50 dialyzer (K242053) and Prismaflex… | 2025 |
| † | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | 2025 |
| † | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | 2022 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 36 ancestors have a recall of any class.
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. 2026, 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 multiFlux 130 and 160 filters are intended for single use only for extracorporeal blood purification during continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF) using pre-, post- or mixed-dilution modes for patients suffering from acute kidney injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252459: multiFlux 130 (F00013123); multiFlux 160 (F00013124).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252459
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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