510(k) · Cleared

Cleared

Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222

K061254510(k) SpecialCleared Jun 23, 200650-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 Jun 23, 2006 as substantially equivalent to K033416 (Medtronic Perfusion Systems, 2003) and 1 other predicate after a 50-day review. Its family tree reaches back 4 generations to 1984. 8 later devices descend from it.

Decided: Jun 23, 2006
Review: 50 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K840002 (1984). 7 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984 · Recalled
3 generations backK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
2 generations backK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
1 generation backK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
This deviceK061254 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
Descendant · 4 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025
Descendant · cites it directly · 1 of its ownK150422 EOPA 3D Arterial CannulaMedtronic, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011high 3 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · 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 · 3 generations on2descendants
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 4 generations on1descendant
K150422EOPA 3D Arterial CannulaMedtronic, Inc. · 2015 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K840002	Arterial Cannula Curved Beveled Tip	Dlp, Inc.	1984	3
−3	K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.	Medtronic Cardiac Surgical Products	2001	1
−2	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…	Medtronic Perfusion Systems	2003	2
−1	K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	1
0 (this device)	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	—
+4	K251258	MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula	Medtronic, Inc.	2025	—
+1	K150422	EOPA 3D Arterial Cannula	Medtronic, Inc.	2015	—

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
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K061254, 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

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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
*	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial… Summary page 1 …ing Classification: Class 11 Predicate Devices: Select 3D Arterial Cannula K033416, K043179 Device Description: The EOPA 3DTM Cannulae have clear flexible, thin wall wire-wound PVC bodies with a t…	Medtronic Perfusion Systems	2003	2
*	K043179	Select 3D Arterial Cannula Summary page 1 …Classification: Class 11 Predicate Devices: Select 3D Arterial Cannula K033416, K043179 Device Description: The EOPA 3DTM Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered di…	Medtronic Perfusion Systems	2005	1

Also cleared against K033416: 3 other devices →

What descends from it? (8)

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
K150422	EOPA 3D Arterial Cannula	Medtronic, Inc.	2015	1

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 22 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
7 of the 7 ancestors have a recall of any class.
Of its descendants, K111972 (Medtronic, Inc., 2011) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K033416.

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/K061254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061254: Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061254

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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