510(k) · Cleared

Recalled · Class II · 2024

Arterial Cannula Curved Beveled Tip

K840002510(k) TraditionalCleared Feb 13, 198441-day reviewClass II21 CFR 870.4210Recalls 3

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

Dlp, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Feb 13, 1984 after a 41-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 3 times.

Decided: Feb 13, 1984
Review: 41 days
Class: Class II
Product code: DWF
Recalls: 3
Predicates: 0

13 later devices descend from it, 3 citing it directly.

This deviceK840002 Arterial Cannula Curved Beveled TipDlp, Inc. · 1984
Descendant · cites it directly · 12 of its ownK013013 Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · Recalled
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 · 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

2001high 3 (2026) · low 0 (2002)2026

Most influential descendants

Showing 5 of 13 · See all

K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 2001 · cites it directly12descendants
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
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K840002	Arterial Cannula Curved Beveled Tip	Dlp, Inc.	1984	—
+1	K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.	Medtronic Cardiac Surgical Products	2001	1
+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	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
2001	1	0
2003	1	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 K840002, 1984–2026Source: 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 14.7 · 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

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

Number	Device	Applicant	Decided	Descendants
K013013	Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.	Medtronic Cardiac Surgical Products	2001	12
K033416	Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial…	Medtronic Perfusion Systems	2003	11
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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 12, 2024	Class II	Z-0986-2025	Packaging	Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Mar 19, 2024	Class II	Z-1793-2024	Process control	Potential for unsealed sterile packing.
May 9, 2008	Not classified	Z-1927-2008	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?

Of its descendants, K013013 (Medtronic Cardiac Surgical Products, 2001) has gone furthest, with 12 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/K840002 · printed Nov 3, 2026

Cite this page

510(k) Report. “K840002: Arterial Cannula Curved Beveled Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K840002

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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