510(k) Report

510(k) · Cleared

Cleared

Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use

K040255510(k) SpecialCleared May 24, 2004110-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

Gambro Renal Products, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 24, 2004 as substantially equivalent to K010985 (Gambro Renal Products, 2001) and 1 other predicate after a 110-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it.

Decided
May 24, 2004
Review
110 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K955592 (1997). 5 ancestors in all, the oldest K902481 (1990). 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1990: 1 other ancestor2005: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant clearedK955592 · Cobe Centrysystem 14 Pes Hemodialyzers · Cobe Renal Care, Inc. · 1997K982414 · Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters · Gambro Healthcare · 1999K030592 · Gambro Polyflux, Model 140H, 170H, 210H · Gambro Renal Care Products · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants K030592 · Gambro Polyflux, Model 140H, 170H, 210H · Gambro Renal Care Products · 2003K982414 · Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters · Gambro Healthcare · 1999K955592 · Cobe Centrysystem 14 Pes Hemodialyzers · Cobe Renal Care, Inc. · 19970
  1. Root · 3 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
  2. 2 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
  3. 1 generation backK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
  4. This deviceK040255 Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004
  5. Descendant · cites it directly · 9 of its ownK043342 Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple…Gambro Renal Products · 2005
  6. 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
  7. 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
  8. Descendant · 3 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  9. Descendant · 3 generations on · 1 of its ownK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 12020: 12023: 12024: 12025: 32026: 3
2005high 3 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all
  • K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products · 2005 · 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
−3K955592Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc.1997—
−2K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare1999—
−1K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products2003—
0 (this device)K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.2004—
+1K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use…Gambro Renal Products2005—
+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
199010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
202010
202310
202410
202530
202630
FIG. 1 — Lineage of K040255, 1997–2026Source: 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
*K010985Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L
Summary page 1
…assification name: High Permeability Hemodialysis System Accessory (876.5860) Predicate Devices: Polyflux 6L, 8L, 1OL Hemodialyzer / Filter K010985; October 10, 2001 Polyflux 140K, 170H, 210H Hemodialyzer / Filter K030592; May 23, 2003 Device Description:…
Gambro Renal Products2001—
*K030592Gambro Polyflux, Model 140H, 170H, 210H
Summary page 1
…Devices: Polyflux 6L, 8L, 1OL Hemodialyzer / Filter K010985; October 10, 2001 Polyflux 140K, 170H, 210H Hemodialyzer / Filter K030592; May 23, 2003 Device Description: The Gambro Polyflux 14L, 17L, and 21 L Capillary Dialyzers/Filters, labeled for single use, h…
Gambro Renal Care Products2003—

Also cleared against K010985: 2 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products20059

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 7 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K043342 (Gambro Renal Products, 2005) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K010985.

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—

What is it indicated for?

The capillary dialyzer Is intended for use in hemodialysis for the treatment of chronic and acute renal failure.

Indications for use as stated in the FDA summary.

Also cleared against K010985

2 other devices cite the same predicate.

  • K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H…Gambro Renal Products · 2005
  • K023615Gambro Polyflux 6 LR, 8 LR and 10 LRGambro Renal Products · 2003

More from Gambro Renal Products, Inc.

13 FDA decisions under this applicant name. See the company

  • K133807Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control UnitGambro Renal Products, Inc. · 20141 recall
  • K131516Prismaflex System 7.10Gambro Renal Products, Inc. · 20144 recalls
  • K130039Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. · 20137 recalls
  • K113313Molecular Adsorbent Recirculating (Mars)Gambro Renal Products, Inc. · 2012
  • K110823PrismaflexGambro Renal Products, Inc. · 20119 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/K040255 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040255: Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040255

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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