510(k) · Cleared

Recalled · Class II · 2026

One Piece Pediatric Arterial Cannula, Model: 77006, 77106

K024069510(k) SpecialCleared Jan 8, 200329-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 Vascular · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jan 8, 2003 as substantially equivalent to K840001 (Dlp, Inc., 1984) after a 29-day review. Its family tree reaches back 1 generation to 1984. 6 later devices descend from it. It has been recalled 2 times.

Decided: Jan 8, 2003
Review: 29 days
Class: Class II
Product code: DWF
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K840001 (1984). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK840001 Arterial Cannula Straight Beveled TipDlp, Inc. · 1984 · Recalled
This deviceK024069 One Piece Pediatric Arterial Cannula, Model: 77006, 77106Medtronic Vascular · 2003
Descendant · cites it directly · 3 of its ownK143083 Bio-Medicus Pediatric Cannula and IntroducersMedtronic, Inc. · 2015 · Recalled
Descendant · 2 generations on · 2 of its ownK201100 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021
Descendant · 3 generations on · 0 of its ownK251831 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2026
Descendant · 3 generations on · 0 of its ownK240534 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2024
Descendant · cites it directly · 0 of its ownK112565 Novaport One Vascular Access CannulaNovalung GmbH · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all

K143083Bio-Medicus Pediatric Cannula and IntroducersMedtronic, Inc. · 2015 · cites it directly3descendants
K201100Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021 · 2 generations on2descendants
K251831Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2026 · 3 generations on0descendants
K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2024 · 3 generations on0descendants
K112565Novaport One Vascular Access CannulaNovalung GmbH · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840001	Arterial Cannula Straight Beveled Tip	Dlp, Inc.	1984	1
0 (this device)	K024069	One Piece Pediatric Arterial Cannula, Model: 77006, 77106	Medtronic Vascular	2003	—
+1	K143083	Bio-Medicus Pediatric Cannula and Introducers	Medtronic, Inc.	2015	1
+2	K201100	Bio-Medicus Life Support Catheter and Introducer	Medtronic, Inc.	2021	—
+3	K251831	Bio-Medicus Life Support Catheter and Introducer	Medtronic, Inc.	2026	—
+3	K240534	Bio-Medicus Life Support Catheter and Introducer	Medtronic, Inc.	2024	—
+1	K112565	Novaport One Vascular Access Cannula	Novalung GmbH	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2011	1	0
2015	1	0
2021	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K024069, 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? (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
*	K840001	Arterial Cannula Straight Beveled Tip Summary page 1 …: Cardiopulmonary bypass vascular catheter, cannula or tubing Classification: Class I1 Predicate Devices: K840001 Arterial Cannula 7000 Series 8, 10, 12, 14…	Dlp, Inc.	1984	1

Also cleared against K840001: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K143083	Bio-Medicus Pediatric Cannula and Introducers	Medtronic, Inc.	2015	3
K112565	Novaport One Vascular Access Cannula	Novalung GmbH	2011	0
K041650	Micro Prime	Innovx Medical, Inc.	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 25, 2026	Class II	Z-2738-2026	Packaging	Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Dec 12, 2024	Class II	Z-0984-2025	Packaging	Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K143083 (Medtronic, Inc., 2015) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K840001.

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 cardiopulmonary bypass, up to six hours or less.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024069 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024069: One Piece Pediatric Arterial Cannula, Model: 77006, 77106.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024069

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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