510(k) Report

510(k) · Cleared

Cleared

Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L

K010985510(k) TraditionalCleared Oct 10, 2001191-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 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Oct 10, 2001 after a 191-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Oct 10, 2001
Review
191 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
0

12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2003: 1 descendant cleared2005: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK010985 Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model…Gambro Renal Products · 2001
  2. Descendant · cites it directly · 10 of its ownK040255 Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004
  3. Descendant · cites it directly · 10 of its ownK023615 Gambro Polyflux 6 LR, 8 LR and 10 LRGambro Renal Products · 2003
  4. Descendant · cites it directly · 9 of its ownK043342 Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple…Gambro Renal Products · 2005
  5. 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
  6. 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

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12020: 12023: 12024: 12025: 32026: 3
2003high 3 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all
  • K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004 · cites it directly10descendants
  • K023615Gambro Polyflux 6 LR, 8 LR and 10 LRGambro Renal Products · 2003 · cites it directly10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010985Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10LGambro Renal Products2001—
+1K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.2004—
+1K023615Gambro Polyflux 6 LR, 8 LR and 10 LRGambro Renal Products2003—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
202010
202310
202410
202530
202630
FIG. 1 — Lineage of K010985, 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
Get a 510(k) Report

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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.200410
K023615Gambro Polyflux 6 LR, 8 LR and 10 LRGambro Renal Products200310
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?

  • Of its descendants, K040255 (Gambro Renal Products, Inc., 2004) has gone furthest, with 10 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 Gambro Renal Products

24 FDA decisions under this applicant name. See the company

  • K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
  • K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 20081 recall
  • K070414Gambro Cartridge Blood SetsGambro Renal Products · 200712 recalls
  • K063290Gambro Quickset BloodlinesGambro Renal Products · 2007
  • K062090Prisma System R03.10AGambro Renal Products · 2006

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/K010985 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010985: Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010985

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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