510(k) Report

510(k) · Cleared

Cleared

Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

K043342510(k) TraditionalCleared May 27, 2005172-day reviewClass II21 CFR 876.5820

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

Gambro Renal Products · FJI Dialyzer, Capillary, Hollow Fiber

Cleared on May 27, 2005 as substantially equivalent to K040255 (Gambro Renal Products, Inc., 2004) and 6 other predicates after a 172-day review. Its family tree reaches back 4 generations to 1997. 9 later devices descend from it.

Decided
May 27, 2005
Review
172 days
Class
Class II
Product code
FJI
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K955592 (1997). 9 ancestors in all, the oldest K902481 (1990). 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1990: 1 other ancestor2023: 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 · 2003K040255 · Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use · Gambro Renal Products, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants K040255 · Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use · Gambro Renal Products, Inc. · 2004K030592 · 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 · 4 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
  2. 3 generations backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
  3. 2 generations backK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
  4. 1 generation backK040255 Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004
  5. This deviceK043342 Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple…Gambro Renal Products · 2005
  6. Descendant · cites it directly · 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 · 2 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 · 2 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  9. Descendant · 2 generations on · 1 of its ownK240394 multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024
  10. Descendant · cites it directly · 1 of its ownK203062 Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC · 2020

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2020: 12023: 12024: 12025: 32026: 3
2020high 3 (2025) · low 0 (2021)2026

Most influential descendants

Showing 5 of 9 · See all
  • 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 · cites it directly6descendants
  • K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on2descendants
  • K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on1descendant
  • K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC · 2024 · 2 generations on1descendant
  • K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K955592Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc.1997—
−3K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare1999—
−2K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products2003—
−1K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.2004—
0 (this device)K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use…Gambro Renal Products2005—
+1K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL…Fresenius Medical Care Renal Therapies Group, LLC2023—
+2K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX…Fresenius Medical Care Renal Therapies Group, LLC2025—
+2K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC2025—
+2K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC2024—
+1K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
200010
200120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202310
202410
202530
202630
FIG. 1 — Lineage of K043342, 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 FJI? 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? (7)

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
*K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use
Summary page 1
…sification name: High Permeability Hemodialysis System Accessory (876.5860) Predicate Devices: Polyflux 14L, 17L, 21L Hemodialyzer/Filter K040255 Cleared 5/24/2004 Polyflux 140H, 170H, 210H Hemodialyzer / Filter K030592 Cleared 5/23/2003 Polyflux 6LR, 8LR…
Gambro Renal Products, Inc.2004—
*K030592Gambro Polyflux, Model 140H, 170H, 210H
Summary page 1
…vices: Polyflux 14L, 17L, 21L Hemodialyzer/Filter K040255 Cleared 5/24/2004 Polyflux 140H, 170H, 210H Hemodialyzer / Filter K030592 Cleared 5/23/2003 Polyflux 6LR, 8LR, 1OLR Hemodialyzer / Filter K023615 Cleared 5/6/2003 Polyflux 6L, 8L, 1…
Gambro Renal Care Products2003—
*K023615Gambro Polyflux 6 LR, 8 LR and 10 LR
Summary page 1
…24/2004 Polyflux 140H, 170H, 210H Hemodialyzer / Filter K030592 Cleared 5/23/2003 Polyflux 6LR, 8LR, 1OLR Hemodialyzer / Filter K023615 Cleared 5/6/2003 Polyflux 6L, 8L, 10 L Hemodialyzer / Filter K010985 Cleared 10110/2001 Polyflux 24S, 24R…
Gambro Renal Products2003—
*K010985Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L
Summary page 1
…/23/2003 Polyflux 6LR, 8LR, 1OLR Hemodialyzer / Filter K023615 Cleared 5/6/2003 Polyflux 6L, 8L, 10 L Hemodialyzer / Filter K010985 Cleared 10110/2001 Polyflux 24S, 24R Hemodialyzer I Filter K010667 Cleared 6/4/2001 Polyflux 17R, 21R…
Gambro Renal Products2001—
*K010667Gambro Polyflux 24S, Gambro Polyflux 24R
Summary page 1
…6/2003 Polyflux 6L, 8L, 10 L Hemodialyzer / Filter K010985 Cleared 10110/2001 Polyflux 24S, 24R Hemodialyzer I Filter K010667 Cleared 6/4/2001 Polyflux 17R, 21R Hemodialyzer/ Filter K994390 Cleared 10/26/2000 Polyflux 11S, 14S…
Gambro Renal Products2001—
*K994390Gambro Polyflux 17R, Capillary Dialyzer/ Filter
Summary page 1
…110/2001 Polyflux 24S, 24R Hemodialyzer I Filter K010667 Cleared 6/4/2001 Polyflux 17R, 21R Hemodialyzer/ Filter K994390 Cleared 10/26/2000 Polyflux 11S, 14S, 17S, 21S Hemodialyzer / Filter K982414 Cleared 3/26/1999 Device Descript…
Gambro Healthcare2000—
*K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters
Summary page 1
…4/2001 Polyflux 17R, 21R Hemodialyzer/ Filter K994390 Cleared 10/26/2000 Polyflux 11S, 14S, 17S, 21S Hemodialyzer / Filter K982414 Cleared 3/26/1999 Device Description: The Gambro Polyflux family Capillary Dialyzers/Filters, labeled for single and multiple u…
Gambro Healthcare1999—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
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, LLC20236
K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC20201

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 8 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K220721 (Fresenius Medical Care Renal Therapies Group, LLC, 2023) has gone furthest, with 6 descendants of its own.

How does its category compare?

All FJI devices

FJI Dialyzer, Capillary, Hollow Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJI

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJI

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

Recalls per year · FJI

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FJI

145in 2025

2007: 172008: 112009: 32010: 322011: 472012: 2112013: 5532014: 6332015: 5612016: 5622017: 1822018: 112019: 202020: 162021: 122022: 22023: 512024: 1522025: 145
2007high 633 (2014) · low 2 (2022)2025

MAUDE reports naming product code FJI, 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—017
20080—011
20090—03
20100—032
20110—047
20120—0211
20131—0553
20140—0633
20150—0561
20160—0562
20170—0182
20180—011
20191—020
20200—016
20210—012
20220—02
20230—051
20240—0152
20250—1145
20260—0—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

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 FJI

The FJI category page

  • K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC · 2019
  • K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
  • K010366Disposable Storage CapMolded Products, Inc. · 2001
  • K011148Ultraconcentrator SystemInterpore Cross Intl. · 2001
  • K002761Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFresenius Medical Care North America · 20002 recalls

https://510kreport.com/device/K043342 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043342: Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043342

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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