510(k) · Cleared

Recalled · Class II · 2014

Select Cap Arterial Cannula with Pressure Monitoring Line, Model 78818,78820,78822,78824,78918,78920,78922,78924

K010737510(k) SpecialCleared Apr 4, 200123-day reviewClass II21 CFR 870.4210Recalls 1

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

Medtronic Cardiac Surgical Products · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Apr 4, 2001 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled once.

Decided: Apr 4, 2001
Review: 23 days
Class: Class II
Product code: DWF
Recalls: 1
Predicates: 0

13 later devices descend from it, 2 citing it directly.

This deviceK010737 Select Cap Arterial Cannula with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 2001
Descendant · cites it directly · 11 of its ownK033416 Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select…Medtronic Perfusion Systems · 2003 · Recalled
Descendant · 2 generations on · 10 of its ownK043179 Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · Recalled
Descendant · 2 generations on · 8 of its ownK061254 Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006
Descendant · cites it directly · 6 of its ownK031518 Eopa Cap Elongated One-Piece Arterial Cannula with Pressure…Medtronic Vascular · 2003
Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2003high 3 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 13 · See all

K033416Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial…Medtronic Perfusion Systems · 2003 · cites it directly11descendants
K043179Select 3D Arterial CannulaMedtronic Perfusion Systems · 2005 · 2 generations on10descendants
K061254Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222Medtronic Perfusion Systems · 2006 · 2 generations on8descendants
K031518Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…Medtronic Vascular · 2003 · cites it directly6descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010737	Select Cap Arterial Cannula with Pressure Monitoring Line, Model…	Medtronic Cardiac Surgical Products	2001	—
+1	K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap…	Medtronic Perfusion Systems	2003	2
+2	K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	2005	1
+2	K061254	Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222	Medtronic Perfusion Systems	2006	—
+1	K031518	Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line…	Medtronic Vascular	2003	—
+2	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
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 K010737, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial…	Medtronic Perfusion Systems	2003	11
K031518	Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…	Medtronic Vascular	2003	6

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-0998-2014	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K033416 (Medtronic Perfusion Systems, 2003) has gone furthest, with 11 descendants of its own.

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	—

https://510kreport.com/device/K010737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010737: Select Cap Arterial Cannula with Pressure Monitoring Line, Model 78818,78820,78822,78824,78918,78920,78922,78924.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010737

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026