510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Optiflux dialyzer

K152367510(k) TraditionalCleared Oct 29, 201569-day reviewClass II21 CFR 876.5860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fresenius Medical Care North America · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Oct 29, 2015 as substantially equivalent to K123262 (Fresenius Medical Care North America, 2014) after a 69-day review. Its family tree reaches back 9 generations to 2001. 12 later devices descend from it. It has been recalled once.

Decided
Oct 29, 2015
Review
69 days
Class
Class II
Product code
KDI
Recalls
1
Predicates
1

Its longest line of descent runs back 9 generations to K001283 (2001). 23 ancestors in all, the oldest K872364 (1987). 12 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1997: 1 other ancestor1991: 1 other ancestor2020: 3 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2026: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant clearedK001283 · Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K012510 · Modification to: Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K020858 · Nxstage Therapy System · Nxstage Medical, Inc. · 2002K030470 · Nxstage System One · Nxstage Medical, Inc. · 2003K041424 · Nxstage System One · Nxstage Medical, Inc. · 2004K050525 · Nxstage System One · Nxstage Medical, Inc. · 2005 · recalledK062079 · Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 · Baxter Healthcare Corporation · 2006K082414 · Optiflux F250NR, Model 0500325E · Fresenius Medical Care North America · 2008 · recalledK123262 · Optiflux Ultra Dialyzer · Fresenius Medical Care North America · 20141990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 5 other ancestors5 generations back: 3 other ancestors7 generations back: 2 other ancestors8 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K123262 · Optiflux Ultra Dialyzer · Fresenius Medical Care North America · 2014K082414 · Optiflux F250NR, Model 0500325E · Fresenius Medical Care North America · 2008 · recalledK062079 · Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 · Baxter Healthcare Corporation · 2006K050525 · Nxstage System One · Nxstage Medical, Inc. · 2005 · recalledK041424 · Nxstage System One · Nxstage Medical, Inc. · 2004K030470 · Nxstage System One · Nxstage Medical, Inc. · 2003K020858 · Nxstage Therapy System · Nxstage Medical, Inc. · 2002K012510 · Modification to: Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K001283 · Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001−50
  1. Root · 9 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  2. 5 generations between
  3. 3 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
  4. 2 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
  5. 1 generation backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  6. This deviceK152367 Optiflux dialyzerFresenius Medical Care North America · 2015
  7. Descendant · cites it directly · 9 of its ownK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
  8. Descendant · 2 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
  9. Descendant · 3 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
  10. Descendant · 3 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  11. Descendant · 3 generations on · 1 of its ownK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024
Show all 9 generations
  1. Root · 9 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  2. 8 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  3. 7 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
  4. 6 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
  5. 5 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
  6. 4 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
  7. 3 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
  8. 2 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
  9. 1 generation backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  10. This deviceK152367 Optiflux dialyzerFresenius Medical Care North America · 2015

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2017: 12020: 32023: 12024: 12025: 32026: 3
2017high 3 (2020) · low 0 (2018)2026

Most influential descendants

Showing 5 of 12 · See all
  • K162488Optiflux dialyzerFresenius Medical Care North America · 2017 · cites it directly9descendants
  • 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 · 2 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 · 3 generations on2descendants
  • K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
  • K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K001283Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−8K012510Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−7K020858Nxstage Therapy SystemNxstage Medical, Inc.2002—
−6K030470Nxstage System OneNxstage Medical, Inc.2003—
−5K041424Nxstage System OneNxstage Medical, Inc.2004—
−4K050525Nxstage System OneNxstage Medical, Inc.20052
−3K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation2006—
−2K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America20083
−1K123262Optiflux Ultra DialyzerFresenius Medical Care North America2014—
0 (this device)K152367Optiflux dialyzerFresenius Medical Care North America2015—
+1K162488Optiflux dialyzerFresenius Medical Care North America20174
+2K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL…Fresenius Medical Care Renal Therapies Group, LLC2023—
+3K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX…Fresenius Medical Care Renal Therapies Group, LLC2025—
+3K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC2025—
+3K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199110
199410
199710
199820
200010
200120
200310
200410
200510
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202030
202310
202410
202530
202630
FIG. 1 — Lineage of K152367, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K123262Optiflux Ultra Dialyzer
Summary page 4
…te Device The predicate devices are the FMCRTG, LLC Optiflux Ultra dialyzers, model numbers F160, F180, F190, F210 and F230. The Optiflux Ultra dialyzers were cleared in K123262 (06 January 2014). The Optiflux Ultra dialyzers have not been the subject of a design-related recall. 5.4. Device Descript…
Fresenius Medical Care North America2014—

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162488Optiflux dialyzerFresenius Medical Care North America20179
K192707Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC20200
K192928Optiflux Enexa F500 DialyzerFresenius Medical Care Reanal Therapies Group, LLC20200

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 5, 2018Class IIZ-0658-2019OtherPotential 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 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 7 of the 23 ancestors have a recall of any class.
  • Of its descendants, K162488 (Fresenius Medical Care North America, 2017) has gone furthest, with 9 descendants of its own.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

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.

More from Fresenius Medical Care North America

42 FDA decisions under this applicant name. See the company

  • K252181AquaAFresenius Medical Care North America · 2025
  • K162488Optiflux dialyzerFresenius Medical Care North America · 20174 recalls
  • K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America · 2015
  • K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  • K131611Fresenius Dry Acid Dissolution UnitsFresenius Medical Care North America · 20132 recalls

Recent decisions in KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K152367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152367: 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/K152367

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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