510(k) · Cleared
Recalled · Class II · 2025Optiflux dialyzer
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 Apr 6, 2017 as substantially equivalent to K152367 (Fresenius Medical Care North America, 2015) after a 211-day review. Its family tree reaches back 10 generations to 2001. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 6, 2017
- Review
- 211 days
- Class
- Class II
- Product code
- KDI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001283 (2001). 24 ancestors in all, the oldest K872364 (1987). 9 later devices descend from it, 3 citing it directly.
- 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 deviceK162488 Optiflux dialyzerFresenius Medical Care North America · 2017
- Descendant · cites it directly · 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 · 2 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
- Descendant · 2 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
- Descendant · 2 generations on · 1 of its ownK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024
- Descendant · cites it directly · 1 of its ownK203062 Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius 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 deviceK162488 Optiflux dialyzerFresenius Medical Care North America · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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 · cites it directly6descendants
- K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on2descendants
- K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on1descendant
- K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 2 generations on1descendant
- K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly1descendant
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) | K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017 | — |
| +1 | 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 | — |
| +2 | K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
| +2 | K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
| +2 | K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024 | — |
| +1 | K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K152367 | Optiflux dialyzerSummary page 4…Predicate Device The predicate devices are the FMCRTG, LLC Optiflux dialyzers, model numbers F160NR, F180NR, F200NR and F250NR. The Optiflux dialyzers were cleared under K152367 (29 October 2015). The Optiflux dialyzers have not been the subject of a design-related recall. Device Description The Optiflux… | 2015 |
What descends from it? (9)
3 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 |
|---|---|---|---|---|
| Aug 29, 2025 | Class II | Z-0041-2026 | Device Design | To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix… |
| Dec 5, 2024 | Class II | Z-0801-2025 | Process control | Potential for internal blood leaks due to cracked polyurethane |
| May 4, 2022 | Class II | Z-1303-2022 | Under Investigation by firm | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. |
| Nov 5, 2018 | Class II | Z-0658-2019 | Other | Potential for external blood leaks from the dialyzer header |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 24 ancestors have a recall of any class.
- Of its descendants, K220721 (Fresenius Medical Care Renal Therapies Group, LLC, 2023) has gone furthest, with 6 descendants of its own.
- 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. 2017, 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 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/K162488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162488: Optiflux dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162488
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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