510(k) · Cleared

Cleared

MC2X Multi-Stage Venous Cannula

K031776510(k) SpecialCleared Jul 25, 200345-day reviewClass II21 CFR 870.4210

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

Medtronic Perfusion Systems · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jul 25, 2003 as substantially equivalent to K915268 (Dlp, Inc., 1992) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.

Decided: Jul 25, 2003
Review: 45 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K891687 (1989). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK891687 Extracorporeal Circuit with Bio-Active SurfaceMedtronic Blood Systems, Inc. · 1989 · Recalled
This deviceK031776 MC2X Multi-Stage Venous CannulaMedtronic Perfusion Systems · 2003
Descendant · cites it directly · 6 of its ownK052372 MC2X Multi-Stage Venous Cannula, Models 91437, 91437CMedtronic Perfusion Systems · 2005
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · 2 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 3 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 2 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all

K052372MC2X Multi-Stage Venous Cannula, Models 91437, 91437CMedtronic Perfusion Systems · 2005 · cites it directly6descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 2 generations on2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891687	Extracorporeal Circuit with Bio-Active Surface	Medtronic Blood Systems, Inc.	1989	10
0 (this device)	K031776	MC2X Multi-Stage Venous Cannula	Medtronic Perfusion Systems	2003	—
+1	K052372	MC2X Multi-Stage Venous Cannula, Models 91437, 91437C	Medtronic Perfusion Systems	2005	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+2	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+3	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2011	1	0
2012	1	0
2014	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K031776, 1989–2026Source: 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 DWF? 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 DWF device

#1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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
*	K915268	Catheter Two Stage Venous Return Summary page 1 …heter, cannula or tubing Classification: Class I1 Predicate Devices: Two Stage Venous Cannula K915268 Extracorporeal Circuit with Bio-Active Surface K89 1687 De…	Dlp, Inc.	1992	—
*	K891687	Extracorporeal Circuit with Bio-Active Surface Summary page 1 …ices: Two Stage Venous Cannula K915268 Extracorporeal Circuit with Bio-Active Surface K89 1687 Device Description: The MC2 family of cannula, including the new MC2XTMMulti-Stage Venous Cannula, are one piece,…	Medtronic Blood Systems, Inc.	1989	10

Also cleared against K915268: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K052372	MC2X Multi-Stage Venous Cannula, Models 91437, 91437C	Medtronic Perfusion Systems	2005	6
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K052372 (Medtronic Perfusion Systems, 2005) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K915268.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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	2	—	25	121
2008	6	95	25	126
2009	8	148	21	99
2010	3	62	26	197
2011	5	85	13	212
2012	10	110	37	233
2013	9	110	14 (1)	238
2014	14	110	6	325
2015	9	46	3 (1)	218
2016	3	32	3	144
2017	5	127	2 (1)	101
2018	5	30	10	118
2019	3	120	2	179
2020	3	30	0	142
2021	5	358	3	162
2022	2	—	0	276
2023	2	—	0	470
2024	3	29	4	401
2025	4	89	0	1,020
2026	8	81	20	—

What is it indicated for?

This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031776 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031776: MC2X Multi-Stage Venous Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031776

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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