510(k) · Cleared

Cleared

Syntra + Dialyzer, Model 200

K023664510(k) TraditionalCleared Feb 21, 2003113-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 Feb 21, 2003 as substantially equivalent to K002210 (Baxter Healthcare Corp, 2001) after a 113-day review. Its family tree reaches back 1 generation to 2001.

Decided: Feb 21, 2003
Review: 113 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002210 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK002210 Syntra Dialyzer, Model Syntra 120, 160Baxter Healthcare Corp · 2001
This deviceK023664 Syntra + Dialyzer, Model 200Baxter Healthcare Corp · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002210	Syntra Dialyzer, Model Syntra 120, 160	Baxter Healthcare Corp	2001	—
0 (this device)	K023664	Syntra + Dialyzer, Model 200	Baxter Healthcare Corp	2003	—

FIG. 1 — Lineage of K023664, 2001–2003Source: 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? (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
*	K002210	Syntra Dialyzer, Model Syntra 120, 160 Summary page 2 …l design and material of the SyntraTM+ Technological Dialyzer is similar to the SyntraTMDialyzers cleared under Characteristics K002210, and do not raise any new types of safety and Compared to the effectiveness issues, when compared to the pred…	Baxter Healthcare Corp	2001	—

Also cleared against K002210: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K002210.

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 SyntraTM+ is indicated for patients with 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/K023664 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023664: Syntra + Dialyzer, Model 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023664

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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