510(k) Report

510(k) · Cleared

Cleared

Gambro Polyflux 6 LR, 8 LR and 10 LR

K023615510(k) TraditionalCleared May 6, 2003190-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 · MSF Hemodialyzer, Re-Use, High Flux

Cleared on May 6, 2003 as substantially equivalent to K010985 (Gambro Renal Products, 2001) after a 190-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.

Decided
May 6, 2003
Review
190 days
Class
Class II
Product code
MSF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010985 (2001). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant clearedK010985 · Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L · Gambro Renal Products · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants K010985 · Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L · Gambro Renal Products · 20010
  1. Root · 1 generation backK010985 Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model…Gambro Renal Products · 2001
  2. This deviceK023615 Gambro Polyflux 6 LR, 8 LR and 10 LRGambro Renal Products · 2003
  3. Descendant · cites it directly · 9 of its ownK043342 Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple…Gambro Renal Products · 2005
  4. 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
  5. 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
  6. Descendant · 3 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  7. 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
−1K010985Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10LGambro Renal Products2001—
0 (this device)K023615Gambro 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—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
202010
202310
202410
202530
202630
FIG. 1 — Lineage of K023615, 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 MSF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K010985Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L
Summary page 1
…nd 1OL Capillary Dialyzers/ Filters labeled for single use which have been previously cleared by the FDA under a 5 1O(k) Notification for single use (510(k) Notification K010985). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types…
Gambro Renal Products2001—

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?

  • Its one ancestor has no 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 MSF devices

MSF Hemodialyzer, Re-Use, High Flux: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSF

FDA has decided no MSF device since 2007.

Median 510(k) review, days · MSF

Too few MSF 510(k)s in any year since 2007 to give a median.

Recalls per year · MSF

No recall names MSF since 2007.

Adverse event reports per year · MSF

1in 2023

2007: 5092008: 6592010: 52011: 162013: 12014: 12015: 12023: 1
2007high 659 (2008) · low 0 (2009)2025

MAUDE reports naming product code MSF, 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
20070—0509
20080—0659
20090—00
20100—05
20110—016
20120—00
20130—01
20140—01
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

POLYFLUX LR is intended for use in hemodialysis for the treatment of acute and chronic renal failure.

The POLYFLUX LR may be reprocessed for reuse on the same patient.

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
  • K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004

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 MSF

The MSF category page

  • K994390Gambro Polyflux 17R, Capillary Dialyzer/ FilterGambro Healthcare · 2000
  • K970681Altra Nova 200 HemodialyzerAlthin Medical AB an Affiliate of Baxter Intl · 1998
  • K970679Altra Flux 200 HemodialyzerAlthin Medical AB an Affiliate of Baxter Intl · 1998
  • K970653Cahp High Performance Cellulose Diacetate (Capillary, Hollow Fiber)Baxter Healthcare Corp · 1998
  • K970662CA Cellulose Acetate Hollow Fiber Dialyzer (CA-170/CA-210)Baxter Healthcare Corp · 1998

https://510kreport.com/device/K023615 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023615: Gambro Polyflux 6 LR, 8 LR and 10 LR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023615

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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