510(k) · Cleared
ClearedOptiflux F180NR Dialyzer
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 Sep 21, 2020 as substantially equivalent to K152367 (Fresenius Medical Care North America, 2015) after a 360-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Sep 21, 2020
- Review
- 360 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001283 (2001). 24 ancestors in all, the oldest K872364 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 6 generations between
- 3 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- 2 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- 1 generation backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- This deviceK192707 Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC · 2020
Show all 10 generations
- Root · 10 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 9 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 8 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 7 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 6 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 5 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 4 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- 3 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- 2 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- 1 generation backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- This deviceK192707 Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −9 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −8 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −7 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −6 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −5 | K050525 | Nxstage System One | Nxstage Medical, Inc. | 2005 | 2 |
| −4 | K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 | Baxter Healthcare Corporation | 2006 | — |
| −3 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| −2 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| −1 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
| 0 (this device) | K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
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 |
| 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? (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 |
|---|---|---|---|
| * | K152367 | Optiflux dialyzerSummary page 4…Gastroenterology/Urology 5.3. Legally Marketed Predicate Device The legally marketed predicate device is the Optiflux F180NRe dialyzer cleared under K152367. This device has not been subject to a design-related recall. 5.4. Device Description 5.4.1. Device Identi… | 2015 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 24 ancestors have a recall of any class.
- 2 other devices also cite its predicate K152367.
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. 2020, 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?
Optiflux Dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192707: Optiflux F180NR Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192707
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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