510(k) · Cleared

Cleared

Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters

K982414510(k) TraditionalCleared Mar 26, 1999256-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 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Mar 26, 1999 as substantially equivalent to K955592 (Cobe Renal Care, Inc., 1997) after a 256-day review. Its family tree reaches back 1 generation to 1997. 36 later devices descend from it.

Decided: Mar 26, 1999
Review: 256 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955592 (1997). 36 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK955592 Cobe Centrysystem 14 Pes HemodialyzersCobe Renal Care, Inc. · 1997
This deviceK982414 Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
Descendant · cites it directly · 19 of its ownK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
Descendant · 2 generations on · 10 of its ownK040255 Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004
Descendant · cites it directly · 10 of its ownK994390 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 · cites it directly · 7 of its ownK014152 Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2000high 5 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 36 · See all

K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003 · cites it directly19descendants
K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004 · 2 generations on10descendants
K994390Gambro Polyflux 17R, Capillary Dialyzer/ FilterGambro Healthcare · 2000 · cites it directly10descendants
K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products · 2005 · cites it directly9descendants
K014152Nxstage Cartridge ExpressNxstage Medical, Inc. · 2002 · cites it directly7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955592	Cobe Centrysystem 14 Pes Hemodialyzers	Cobe Renal Care, Inc.	1997	—
0 (this device)	K982414	Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters	Gambro Healthcare	1999	—
+1	K030592	Gambro Polyflux, Model 140H, 170H, 210H	Gambro Renal Care Products	2003	—
+2	K040255	Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use	Gambro Renal Products, Inc.	2004	—
+1	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	—
+1	K014152	Nxstage Cartridge Express	Nxstage Medical, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2003	2	0
2004	1	0
2005	4	0
2006	2	0
2007	1	0
2012	1	0
2013	3	0
2016	1	0
2019	1	0
2020	2	0
2022	2	0
2023	2	0
2024	4	0
2025	5	0
2026	3	0

FIG. 1 — Lineage of K982414, 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 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 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K955592	Cobe Centrysystem 14 Pes Hemodialyzers Summary page 1 …his hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592) (please refer to Parts A., B. C. and D. of Section XIV. of this Notification for information on the Cobe Centrysystem 14 PES Hem…	Cobe Renal Care, Inc.	1997	—

Also cleared against K955592: 1 other device →

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K030592	Gambro Polyflux, Model 140H, 170H, 210H	Gambro Renal Care Products	2003	19
K994390	Gambro Polyflux 17R, Capillary Dialyzer/ Filter	Gambro Healthcare	2000	10
K043342	Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…	Gambro Renal Products	2005	9
K014152	Nxstage Cartridge Express	Nxstage Medical, Inc.	2002	7
K050603	Olpur Dialyzer, Model HD 190	Nephros, Inc.	2005	6

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, K030592 (Gambro Renal Care Products, 2003) has gone furthest, with 19 descendants of its own.
1 other device also cites its predicate K955592.

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

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	91	4	916
2008	6	148	0	1,042
2009	4	236	3	522
2010	9	186	1	823
2011	5	85	4	2,270
2012	6	153	1	1,765
2013	11	247	2	2,360
2014	8	164	3	6,154
2015	5	69	5	4,182
2016	5	230	4	766
2017	8	188	1	963
2018	2	—	1	1,716
2019	4	263	6	1,587
2020	9	266	0	1,633
2021	2	—	2	1,944
2022	7	259	17	2,180
2023	7	157	8 (8)	2,692
2024	7	235	4 (2)	2,441
2025	9	199	2	2,786
2026	6	154	2	—

What is it indicated for?

The Gambro Polyflux 118, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.

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/K982414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982414

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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