510(k) Report

510(k) · Cleared

Cleared

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

K220721510(k) TraditionalCleared May 11, 2023423-day reviewClass II21 CFR 876.5860

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

Fresenius Medical Care Renal Therapies Group, LLC · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 11, 2023 as substantially equivalent to K162488 (Fresenius Medical Care North America, 2017) and 1 other predicate after a 423-day review. Its family tree reaches back 11 generations to 2001. 6 later devices descend from it.

Decided
May 11, 2023
Review
423 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). 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2004: 2 other ancestors2003: 3 other ancestors2001: 3 other ancestors2000: 2 other ancestors1999: 1 other ancestor1997: 2 other ancestors1990: 1 other ancestor2009: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1991: 1 other ancestor2025: 3 descendants cleared2024: 1 descendant cleared2026: 2 descendants clearedReference device: K162248 · Asahi ViE-U Series Dialyzer · Asahi Kasei Medical Co., Ltd. · 2017K001283 · 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 · 2014K152367 · Optiflux dialyzer · Fresenius Medical Care North America · 2015 · recalledK162488 · Optiflux dialyzer · Fresenius Medical Care North America · 2017 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 7 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor6 generations back: 4 other ancestors7 generations back: 3 other ancestors9 generations back: 2 other ancestors10 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants K162488 · Optiflux dialyzer · Fresenius Medical Care North America · 2017 · recalledK152367 · Optiflux dialyzer · Fresenius Medical Care North America · 2015 · recalledK123262 · 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. · 2001−10−50
  1. Root · 11 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  4. 2 generations backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
  5. 1 generation backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
  6. This deviceK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
  7. Descendant · cites it directly · 2 of its ownK243874 FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100…Fresenius Medical Care Renal Therapies Group, LLC · 2025
  8. Descendant · cites it directly · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  9. Descendant · cites it directly · 1 of its ownK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024
  10. Descendant · 2 generations on · 0 of its ownK261267 Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  11. Descendant · 2 generations on · 0 of its ownK252459 multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026
Show all 11 generations
  1. Root · 11 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  2. 10 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  3. 9 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
  4. 8 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
  5. 7 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
  6. 6 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
  7. 5 generations backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
  8. 4 generations backK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
  9. 3 generations backK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  10. 2 generations backK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
  11. 1 generation backK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled
  12. This deviceK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2024: 12025: 32026: 2
2024high 3 (2025) · low 1 (2024)2026

Most influential descendants

Showing 5 of 6 · See all
  • K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · cites it directly2descendants
  • K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · cites it directly1descendant
  • K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · cites it directly1descendant
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026 · 2 generations on0descendants
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K001283Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−10K012510Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−9K020858Nxstage Therapy SystemNxstage Medical, Inc.2002—
−8K030470Nxstage System OneNxstage Medical, Inc.2003—
−7K041424Nxstage System OneNxstage Medical, Inc.2004—
−6K050525Nxstage System OneNxstage Medical, Inc.20052
−5K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation2006—
−4K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America20083
−3K123262Optiflux Ultra DialyzerFresenius Medical Care North America2014—
−2K152367Optiflux dialyzerFresenius Medical Care North America20151
−1K162488Optiflux dialyzerFresenius Medical Care North America20174
0 (this device)K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL…Fresenius Medical Care Renal Therapies Group, LLC2023—
+1K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX…Fresenius Medical Care Renal Therapies Group, LLC2025—
+1K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC2025—
+1K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC2024—
+2K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC2026—
+2K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199010
199110
199410
199720
199820
199910
200020
200130
200330
200420
200520
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202530
202620
FIG. 1 — Lineage of K220721, 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K162488Optiflux dialyzer
Summary page 4
…Urology 5.3. Legally Marketed Predicate Device The legally marketed predicate devices are the F160NR, F180NR, F200NR, and F250NR 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…
Fresenius Medical Care North America20174
*K043342Polyflux 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) are used as secondary predicate devices to support the expanded Indications for Use statement. The Asahi ViE-U Dialyzer (K162248…
Gambro Renal Products2005—
†K162248Asahi ViE-U Series DialyzerAsahi Kasei Medical Co., Ltd.2017—

Also cleared against K162488: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC20252
K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251
K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC20241

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 22 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, K243874 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K162488.

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. 2023, 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?

FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in 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.

Also cleared against K162488

2 other devices cite the same predicate.

  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC · 2020

More from Fresenius Medical Care Renal Therapies…

53 FDA decisions under this applicant name. See the company

  • 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
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026

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/K220721 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220721

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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