510(k) · Cleared

Cleared

Gambro Polyflux 17R, Capillary Dialyzer/ Filter

K994390510(k) TraditionalCleared Oct 26, 2000303-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 Healthcare · MSF Hemodialyzer, Re-Use, High Flux

Cleared on Oct 26, 2000 as substantially equivalent to K982414 (Gambro Healthcare, 1999) after a 303-day review. Its family tree reaches back 2 generations to 1997. 10 later devices descend from it.

Decided: Oct 26, 2000
Review: 303 days
Class: Class II
Product code: MSF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K955592 (1997). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
1 generation backK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
This deviceK994390 Gambro Polyflux 17R, Capillary Dialyzer/ FilterGambro Healthcare · 2000
Descendant · cites it directly · 9 of its ownK043342 Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple…Gambro Renal Products · 2005
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
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
Descendant · 3 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
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

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

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955592	Cobe Centrysystem 14 Pes Hemodialyzers	Cobe Renal Care, Inc.	1997	—
−1	K982414	Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters	Gambro Healthcare	1999	—
0 (this device)	K994390	Gambro Polyflux 17R, Capillary Dialyzer/ Filter	Gambro Healthcare	2000	—
+1	K043342	Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use…	Gambro Renal Products	2005	—
+2	K220721	FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL…	Fresenius Medical Care Renal Therapies Group, LLC	2023	—
+3	K243874	FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX…	Fresenius Medical Care Renal Therapies Group, LLC	2025	—
+3	K242053	FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)	Fresenius Medical Care Renal Therapies Group, LLC	2025	—
+3	K240394	multiFlux 1000 (F00012408)	Fresenius Medical Care Renal Therapies Group, LLC	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2020	1	0
2023	1	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K994390, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K982414	Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters Summary page 1 …flux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). A copy of this approval letter is included in Appendix I of this Notification. Blood enters a blood inlet port where it is dis…	Gambro Healthcare	1999	—

Also cleared against K982414: 4 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K043342	Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…	Gambro Renal Products	2005	9

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 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K043342 (Gambro Renal Products, 2005) has gone furthest, with 9 descendants of its own.
4 other devices also cite its predicate K982414.

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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	509
2008	—	659
2009	—	0
2010	—	5
2011	—	16
2012	—	0
2013	—	1
2014	—	1
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	1
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use.

CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed.

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K994390 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994390: Gambro Polyflux 17R, Capillary Dialyzer/ Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994390

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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