510(k) · Cleared
Recalled · Class II · 2014Optiflux F250NR, Model 0500325E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Oct 28, 2008 as substantially equivalent to K062079 (Baxter Healthcare Corporation, 2006) and 1 other predicate after a 68-day review. Its family tree reaches back 7 generations to 2001. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 28, 2008
- Review
- 68 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001283 (2001). 20 ancestors in all, the oldest K872364 (1987). 16 later devices descend from it, 2 citing it directly.
- 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 deviceK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008
- Descendant · cites it directly · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- Descendant · 2 generations on · 12 of its ownK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- Descendant · 3 generations on · 9 of its ownK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- Descendant · 4 generations on · 6 of its ownK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
- Descendant · 5 generations on · 2 of its ownK243874 FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · cites it directly13descendants
- K152367Optiflux dialyzerFresenius Medical Care North America · 2015 · 2 generations on12descendants
- K162488Optiflux dialyzerFresenius Medical Care North America · 2017 · 3 generations on9descendants
- K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX…Fresenius Medical Care Renal Therapies Group, LLC · 2023 · 4 generations on6descendants
- K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 5 generations on2descendants
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) | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | — |
| +1 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| +2 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
| +3 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 4 |
| +4 | 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 | — |
| +5 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
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 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Summary page 2…ux F250NR dialyzer is substantially equivalent to the Baxter Xenium 210 dialyzer and the Rexeed 25S dialyzer. Baxter Xenium Dialyzer Model 210 * K062079 (10/19/2006) Asahi Kasei Rexeed Dialyzer Model 25S a K051187 (6/8/05) D. Indications for Use/intended Use… | 2006 |
| * | K051187 | Rexeed Series DialyzersSummary page 2…er and the Rexeed 25S dialyzer. Baxter Xenium Dialyzer Model 210 * K062079 (10/19/2006) Asahi Kasei Rexeed Dialyzer Model 25S a K051187 (6/8/05) D. Indications for Use/intended Use: The Optiflux F25ONR dialyzers are intended for patients with acute or chronic r… | 2005 |
What descends from it? (16)
See all 162 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2014 | Class II | Z-1105-2014 | Under Investigation by firm | Dialysate Port Leak During Priming of the Dialyzers |
| Dec 27, 2011 | Not classified | Z-0825-2012 | Process control | Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak |
| Feb 16, 2011 | Not classified | Z-1622-2011 | Process control | There is an increased risk of an internal blood leak. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 6 of the 20 ancestors have a recall of any class.
- Of its descendants, K123262 (Fresenius Medical Care North America, 2014) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K062079.
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. 2008, 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 Fresenius Optiflux® F25ONR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082414: Optiflux F250NR, Model 0500325E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082414
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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