510(k) · Cleared

Cleared

Gambro Polyflux, Model 140H, 170H, 210H

K030592510(k) TraditionalCleared May 23, 200387-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 Care Products · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 23, 2003 as substantially equivalent to K982414 (Gambro Healthcare, 1999) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1997. 19 later devices descend from it.

Decided: May 23, 2003
Review: 87 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K955592 (1997). 3 ancestors in all, the oldest K902481 (1990). 19 later devices descend from it, 6 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 deviceK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
Descendant · cites it directly · 10 of its ownK040255 Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004
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 · cites it directly · 2 of its ownK060195 Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseGambro Renal Products · 2006 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2004high 3 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 19 · See all

K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004 · 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
K060195Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseGambro Renal Products · 2006 · cites it directly2descendants

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)	K030592	Gambro Polyflux, Model 140H, 170H, 210H	Gambro Renal Care Products	2003	—
+1	K040255	Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use	Gambro Renal Products, Inc.	2004	—
+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	—
+1	K060195	Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use	Gambro Renal Products	2006	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	1	0
2007	1	0
2013	1	0
2016	1	0
2020	2	0
2022	1	0
2023	2	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K030592, 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? (2)

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 …o POLYFLUX 14S, 17s and 21s Hemodialyzers /filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K982414). A copy of this clearance letter is included in Section X. D of this Notification. Blood enters a blood inlet port where it is…	Gambro Healthcare	1999	—
*	K902481	Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber Summary page 1 …are made of polycarbonate. The design and incorporation of the silicone header gasket is the same as previously approved for the Gambro GFS Plus Hemodialyzers / Filters(K90248 1). The Page 20…	Gambro, Inc.	1990	—

Also cleared against K982414: 4 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K040255	Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use	Gambro Renal Products, Inc.	2004	10
K043342	Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…	Gambro Renal Products	2005	9
K060195	Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single Use	Gambro Renal Products	2006	2
K193542	Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22	Bellco Srl	2020	1
K051520	Gambro Polyflux Hemodialyzer, Model 6H	Gambro Renal Products	2005	1
K213639	Revaclear 500, Revaclear 400, Revaclear 300	Baxter Healthcare Corporation	2022	0

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 6 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K040255 (Gambro Renal Products, Inc., 2004) has gone furthest, with 10 descendants of its own.
4 other devices also cite its predicate K982414.

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 capillary dialyzer/filter is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatments of chronic or acute renal failure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030592 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030592: Gambro Polyflux, Model 140H, 170H, 210H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030592

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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