510(k) · Cleared

Recalled · Class II · 2014

Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface

K033416510(k) SpecialCleared Nov 5, 20039-day reviewClass II21 CFR 870.4210Recalls 2

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 Nov 5, 2003 as substantially equivalent to K840002 (Dlp, Inc., 1984) and 4 other predicates after a 9-day review. Its family tree reaches back 2 generations to 1984. 11 later devices descend from it. It has been recalled 2 times.

Decided: Nov 5, 2003
Review: 9 days
Class: Class II
Product code: DWF
Recalls: 2
Predicates: 5

Its longest line of descent runs back 2 generations to K840002 (1984). 5 ancestors in all. 11 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
1 generation backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
This deviceK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003
Descendant · cites it directly · 10 of its ownK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
Descendant · cites it directly · 8 of its ownK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
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 · 3 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005high 3 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all

K043179Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · cites it directly10descendants
K061254Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006 · cites it directly8descendants
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 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K840002	Arterial Cannula Curved Beveled Tip	Dlp, Inc.	1984	3
−1	K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.	Medtronic Cardiac Surgical Products	2001	1
0 (this device)	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…	Medtronic Perfusion Systems	2003	—
+1	K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	1
+1	K061254	Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222	Medtronic Perfusion Systems	2006	—
+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
+3	K140165	MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…	Medtronic, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2011	1	0
2012	1	0
2014	2	0
2015	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K033416, 1984–2026Source: 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? (5)

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
*	K840002	Arterial Cannula Curved Beveled Tip Summary page 1 …tubing Classification: Class I1 Predicate Devices: Arterial Cannula K840002, K000776, K013013, KO10737 Extracorporeal Circuit with BioActive Surface K…	Dlp, Inc.	1984	3
*	K000776	Medtronic DLP Arterial Cannulae with 3D Tip Summary page 1 …bing Classification: Class I1 Predicate Devices: Arterial Cannula K840002, K000776, K013013, KO10737 Extracorporeal Circuit with BioActive Surface K891687 =…	Medtronic Cardiac Surgical Products	2001	1
*	K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR. Summary page 1 …Classification: Class I1 Predicate Devices: Arterial Cannula K840002, K000776, K013013, KO10737 Extracorporeal Circuit with BioActive Surface K891687 === Page 2…	Medtronic Cardiac Surgical Products	2001	1
*	K010737	Select Cap Arterial Cannula with Pressure Monitoring Line, Model…	Medtronic Cardiac Surgical Products	2001	1
*	K891687	Extracorporeal Circuit with Bio-Active Surface Summary page 1 …annula K840002, K000776, K013013, KO10737 Extracorporeal Circuit with BioActive Surface K891687 Device Description: The Select 3DTM and Select CAPTh*Arterial Cannulae both have clear flexible, thin u .III wire…	Medtronic Blood Systems, Inc.	1989	10

Also cleared against K840002: 2 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	10
K061254	Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222	Medtronic Perfusion Systems	2006	8
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K132451	Sarns Soft-Flow Aortic Cannula	Terumo Cardiovascular Systems Corp.	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 30, 2014	Class II	Z-0999-2014	Under Investigation by firm	Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
May 9, 2008	Not classified	Z-1926-2008	Nonconforming Material/Component	Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
5 of the 5 ancestors have a recall of any class.
Of its descendants, K043179 (Medtronic Perfusion Systems, 2005) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K840002.

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?

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033416 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033416

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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