510(k) · Cleared
ClearedOptiflux Series of Dialyzers F160NR, F180NR, F200NR
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 Dec 28, 2020 as substantially equivalent to K162488 (Fresenius Medical Care North America, 2017) and 1 other predicate after an 80-day review. Its family tree reaches back 11 generations to 2001. 1 later device descends from it.
- Decided
- Dec 28, 2020
- Review
- 80 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001283 (2001). 34 ancestors in all, the oldest K872364 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 7 generations between
- 3 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- 2 generations backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- 1 generation backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- This deviceK203062 Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC · 2020
- Descendant · cites it directly · 0 of its ownK260533 Elisio™-HNipro Medical Corporation · 2026
Show all 11 generations
- Root · 11 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 10 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
- 9 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
- 8 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
- 7 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
- 6 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
- 5 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
- 4 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
- 3 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
- 2 generations backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
- 1 generation backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
- This deviceK203062 Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K260533Elisio™-HNipro Medical Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001283 | Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −10 | K012510 | Modification to: Lifemate Hemofiltration System | Nxstage Medical, Inc. | 2001 | — |
| −9 | K020858 | Nxstage Therapy System | Nxstage Medical, Inc. | 2002 | — |
| −8 | K030470 | Nxstage System One | Nxstage Medical, Inc. | 2003 | — |
| −7 | K041424 | Nxstage System One | Nxstage Medical, Inc. | 2004 | — |
| −6 | 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 | — |
| −4 | K082414 | Optiflux F250NR, Model 0500325E | Fresenius Medical Care North America | 2008 | 3 |
| −3 | K123262 | Optiflux Ultra Dialyzer | Fresenius Medical Care North America | 2014 | — |
| −2 | K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015 | 1 |
| −1 | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | 4 |
| 0 (this device) | K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | — |
| +1 | 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 |
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K162488 | Optiflux dialyzerSummary page 4…terology-Urology 5.3. Legally Marketed Predicate Device The legally marketed predicate devices are the F160NR, F180NR and F200NR Optiflux Dialyzers cleared under K162488. These predicates have not been subject to a design- related recall. The Gambro Polyflux 140H, 170H, and 210H Capillary Dialyzers… | 2017 |
| * | K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Summary page 4…tiflux Dialyzers cleared under K162488. These predicates have not been subject to a design- related recall. The Gambro Polyflux 140H, 170H, and 210H Capillary Dialyzers (K043342) will be used as secondary predicate devices to support the expanded Indications for Use statement. 5.4. Device Descripti… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260533 | Elisio™-H | 2026 | 0 |
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.
- 9 of the 34 ancestors have a recall of any class.
- Of its descendants, K260533 (Nipro Medical Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K162488.
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 hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
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/K203062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203062: Optiflux Series of Dialyzers F160NR, F180NR, F200NR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203062
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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