510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Fresenius Optiflux 200A

K003498510(k) SpecialCleared Jan 4, 200152-day reviewClass II21 CFR 876.5860Recalls 2

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 Jan 4, 2001 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it. It has been recalled 2 times.

Decided
Jan 4, 2001
Review
52 days
Class
Class II
Product code
KDI
Recalls
2
Predicates
0

22 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2005: 1 descendant cleared2013: 2 descendants cleared2008: 2 descendants cleared2015: 2 descendants cleared2014: 2 descendants cleared2026: 3 descendants cleared2020: 3 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2025: 3 descendants cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK003498 Fresenius Optiflux 200AFresenius Medical Care North America · 2001
  2. Descendant · cites it directly · 20 of its ownK051187 Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005 · Recalled
  3. Descendant · 2 generations on · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
  4. Descendant · 3 generations on · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014
  5. Descendant · 4 generations on · 12 of its ownK152367 Optiflux dialyzerFresenius Medical Care North America · 2015 · Recalled
  6. Descendant · 5 generations on · 9 of its ownK162488 Optiflux dialyzerFresenius Medical Care North America · 2017 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12008: 22013: 22014: 22015: 22017: 12020: 32023: 12024: 12025: 32026: 3
2005high 3 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all
  • K051187Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd. · 2005 · cites it directly20descendants
  • K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · 2 generations on16descendants
  • K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · 3 generations on13descendants
  • K152367Optiflux dialyzerFresenius Medical Care North America · 2015 · 4 generations on12descendants
  • K162488Optiflux dialyzerFresenius Medical Care North America · 2017 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003498Fresenius Optiflux 200AFresenius Medical Care North America2001—
+1K051187Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd.20051
+2K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America20083
+3K123262Optiflux Ultra DialyzerFresenius Medical Care North America2014—
+4K152367Optiflux dialyzerFresenius Medical Care North America20151
+5K162488Optiflux dialyzerFresenius Medical Care North America20174

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200820
201320
201420
201520
201710
202030
202310
202410
202530
202630
FIG. 1 — Lineage of K003498, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K051187Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd.200520
K070222Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NFresenius Medical Care North America20070

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 4, 2014Class IIZ-1104-2014Under Investigation by firmDialysate Port Leak During Priming of the Dialyzers
Mar 6, 2012Not classifiedZ-1339-2012Process controlRisk of internal blood leaks affecting the hemodialyzers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051187 (Asahi Kasei Medical Co., Ltd., 2005) has gone furthest, with 20 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.

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—

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
  • K152367Optiflux dialyzerFresenius Medical Care North America · 20151 recall
  • K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014

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/K003498 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003498: Fresenius Optiflux 200A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003498

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026