510(k) · Cleared

Cleared

MC3 Crescent Jugular Dual Lumen Catheter

K203409510(k) TraditionalCleared May 3, 2021165-day reviewClass II21 CFR 870.4100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mc3, Inc. · PZS Dual Lumen Ecmo Cannula

Cleared on May 3, 2021 as substantially equivalent to K180151 (Mc3 Incorporated, 2018) after a 165-day review. Its family tree reaches back 4 generations to 2001.

Decided: May 3, 2021
Review: 165 days
Class: Class II
Product code: PZS
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K003288 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
3 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
2 generations backK171610 MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017
1 generation backK180151 MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 2018
This deviceK203409 MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003288	Origen Dual Lumen Catheter	Origen Biomedical, Inc.	2001	—
−3	K081820	Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR…	Avalon Laboratories, LLC	2008	—
−2	K171610	MC3 QuickFlow Dual Lumen Catheter	Mc3 Incorporated	2017	—
−1	K180151	MC3 Jugular Dual Lumen Catheter	Mc3 Incorporated	2018	—
0 (this device)	K203409	MC3 Crescent Jugular Dual Lumen Catheter	Mc3, Inc.	2021	—

FIG. 1 — Lineage of K203409, 2001–2021Source: 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 PZS? 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 PZS device

#1 K232480 ProtekDuo Veno-Venous Cannula Setsscore 7.3 · 5 generations · no Class I recall

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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
*	K180151	MC3 Jugular Dual Lumen Catheter	Mc3 Incorporated	2018	—
†	K013869	SR Ivocron	Ivoclar Vivadent, Inc.	2002	—
†	K081820	Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR	Avalon Laboratories, LLC	2008	—

Also cleared against K180151: 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?

The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K180151.

How does its category compare?

All PZS devices

PZS Dual Lumen Ecmo Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · PZS

1in 2023

2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PZS

Too few PZS 510(k)s in any year since 2007 to give a median.

Recalls per year · PZS

No recall names PZS since 2007.

Adverse event reports per year · PZS

34in 2025

2007high 34 (2025) · low 0 (2007)2025

MAUDE reports naming product code PZS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	1
2020	0	—	6
2021	1	—	12
2022	0	—	28
2023	1	—	10
2024	0	—	11
2025	0	—	34
2026	0	—	—

What is it indicated for?

The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

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/K203409 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203409: MC3 Crescent Jugular Dual Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203409

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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