510(k) · Cleared

Cleared

Exeltra Plus High Flux Dialyzer, Model 210

K030975510(k) SpecialCleared Apr 25, 200328-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 Apr 25, 2003 as substantially equivalent to K890315 (Baxter Healthcare Corp, 1989) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1989.

Decided: Apr 25, 2003
Review: 28 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K890315 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK890315 Capillary Flow Dialyzers Models CT110G & CT190GBaxter Healthcare Corp · 1989
This deviceK030975 Exeltra Plus High Flux Dialyzer, Model 210Baxter Healthcare Corp · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K890315	Capillary Flow Dialyzers Models CT110G & CT190G	Baxter Healthcare Corp	1989	—
0 (this device)	K030975	Exeltra Plus High Flux Dialyzer, Model 210	Baxter Healthcare Corp	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1998	1	0

FIG. 1 — Lineage of K030975, 1989–2003Source: 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? (3)

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
*	K890315	Capillary Flow Dialyzers Models CT110G & CT190G Summary page 1 …Name: Dialyzer Classification Name: High Permeability Hemodialysis System per 21 CFX 876.58610 Equivalent Predicate: Baxter CT Dialyzer, Single Use (K8903 15, K926568, K970663) Device Description: Models EXELTRATMPlus 210 Single Use Dialyzer Intended Use:…	Baxter Healthcare Corp	1989	—
*	K926568	Baxter CT Dialyzer Summary page 1 …Dialyzer Classification Name: High Permeability Hemodialysis System per 21 CFX 876.58610 Equivalent Predicate: Baxter CT Dialyzer, Single Use (K8903 15, K926568, K970663) Device Description: Models EXELTRATMPlus 210 Single Use Dialyzer Intended Use:…	Baxter Healthcare Corp	1994	—
*	K970663	CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G) Summary page 1 …ame: High Permeability Hemodialysis System per 21 CFX 876.58610 Equivalent Predicate: Baxter CT Dialyzer, Single Use (K8903 15, K926568, K970663) Device Description: Models EXELTRATMPlus 210 Single Use Dialyzer Intended Use: Hemodialysis with EXELTRA TM Pl…	Baxter Healthcare Corp	1998	—

Also cleared against K890315: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 3 ancestors has a recall.
1 other device also cites its predicate K890315.

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?

Hemodialysis with the EXELTRATMPlus Dialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030975 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030975: Exeltra Plus High Flux Dialyzer, Model 210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030975

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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