510(k) · Cleared

Cleared

Baxter CT Dialyzer

K926568510(k) TraditionalCleared Sep 30, 1994638-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

Baxter Healthcare Corp · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Sep 30, 1994 after a 638-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided: Sep 30, 1994
Review: 638 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 0

29 later devices descend from it, 2 citing it directly.

This deviceK926568 Baxter CT DialyzerBaxter Healthcare Corp · 1994
Descendant · cites it directly · 27 of its ownK030974 Exeltra High Flux Dialyzer, Models 150 & 170Baxter Healthcare Corp · 2003
Descendant · 2 generations on · 26 of its ownK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
Descendant · 3 generations on · 20 of its ownK083778 Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
Descendant · 3 generations on · 16 of its ownK082414 Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · Recalled
Descendant · 4 generations on · 13 of its ownK123262 Optiflux Ultra DialyzerFresenius Medical Care North America · 2014

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2003high 6 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 29 · See all

K030974Exeltra High Flux Dialyzer, Models 150 & 170Baxter Healthcare Corp · 2003 · cites it directly27descendants
K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006 · 2 generations on26descendants
K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009 · 3 generations on20descendants
K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 2008 · 3 generations on16descendants
K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014 · 4 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K926568	Baxter CT Dialyzer	Baxter Healthcare Corp	1994	—
+1	K030974	Exeltra High Flux Dialyzer, Models 150 & 170	Baxter Healthcare Corp	2003	—
+2	K062079	Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210	Baxter Healthcare Corporation	2006	—
+3	K083778	Xenium XPH, Models 110, 130, 150, 170, 190 and 210	Baxter Healthcare Corporation	2009	—
+3	K082414	Optiflux F250NR, Model 0500325E	Fresenius Medical Care North America	2008	3
+4	K123262	Optiflux Ultra Dialyzer	Fresenius Medical Care North America	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2006	1	0
2008	1	0
2009	1	0
2010	1	0
2013	6	0
2014	2	0
2015	1	0
2016	1	0
2017	2	0
2020	3	0
2023	1	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K926568, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K030974	Exeltra High Flux Dialyzer, Models 150 & 170	Baxter Healthcare Corp	2003	27
K030975	Exeltra Plus High Flux Dialyzer, Model 210	Baxter Healthcare Corp	2003	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?

Of its descendants, K030974 (Baxter Healthcare Corp, 2003) has gone furthest, with 27 descendants of its own.

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	—

https://510kreport.com/device/K926568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926568: Baxter CT Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926568

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026