510(k) · Cleared

Cleared

MC2X Multi-Stage Venous Cannula, Models 91437, 91437C

K052372510(k) SpecialCleared Sep 22, 200523-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 Sep 22, 2005 as substantially equivalent to K031776 (Medtronic Perfusion Systems, 2003) after a 23-day review. Its family tree reaches back 2 generations to 1989. 6 later devices descend from it.

Decided: Sep 22, 2005
Review: 23 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K891687 (1989). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK891687 Extracorporeal Circuit with Bio-Active SurfaceMedtronic Blood Systems, Inc. · 1989 · Recalled
1 generation backK031776 MC2X Multi-Stage Venous CannulaMedtronic Perfusion Systems · 2003
This deviceK052372 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 · cites it directly · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
Descendant · 3 generations on · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011high 2 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all

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 · cites it directly2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 2 generations on1descendant
K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K891687	Extracorporeal Circuit with Bio-Active Surface	Medtronic Blood Systems, Inc.	1989	10
−1	K031776	MC2X Multi-Stage Venous Cannula	Medtronic Perfusion Systems	2003	—
0 (this device)	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
+1	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—
+2	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—
+3	K262052	Tri Stage Venous Cannulae	Sorin Group Italia S.R.L.	2026	—

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
2011	1	0
2012	1	0
2014	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K052372, 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

Get a 510(k) Report

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
*	K031776	MC2X Multi-Stage Venous Cannula Summary page 1 …tubing Classification: Class II Predicate Devices: MCZXIM Multi-Stage Venous Cannula K031776 Device Description: are cannula withre w bodies wit…	Medtronic Perfusion Systems	2003	—

Also cleared against K031776: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…	Medtronic, Inc.	2014	2

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 16 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K031776.

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052372 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052372: MC2X Multi-Stage Venous Cannula, Models 91437, 91437C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052372

Report an extraction error

Are you the manufacturer?

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