510(k) · Cleared

Recalled · 2008

Arterial Cannula Straight Beveled Tip

K840001510(k) TraditionalCleared Feb 13, 198441-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

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 once.

Decided: Feb 13, 1984
Review: 41 days
Class: Class II
Product code: DWF
Recalls: 1
Predicates: 0

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

This deviceK840001 Arterial Cannula Straight Beveled TipDlp, Inc. · 1984
Descendant · cites it directly · 6 of its ownK024069 One Piece Pediatric Arterial Cannula, Model: 77006, 77106Medtronic Vascular · 2003 · Recalled
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 · 2 generations on · 3 of its ownK143083 Bio-Medicus Pediatric Cannula and IntroducersMedtronic, Inc. · 2015 · Recalled
Descendant · 3 generations on · 2 of its ownK201100 Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2003high 3 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 13 · See all

K024069One Piece Pediatric Arterial Cannula, Model: 77006, 77106Medtronic Vascular · 2003 · cites it directly6descendants
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
K143083Bio-Medicus Pediatric Cannula and IntroducersMedtronic, Inc. · 2015 · 2 generations on3descendants
K201100Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. · 2021 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2011	2	0
2012	1	0
2014	1	0
2015	1	0
2021	1	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K840001, 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 14.6 · 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
K024069	One Piece Pediatric Arterial Cannula, Model: 77006, 77106	Medtronic Vascular	2003	6
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
May 9, 2008	Not classified	Z-1925-2008	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, K024069 (Medtronic Vascular, 2003) has gone furthest, with 6 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/K840001 · printed Nov 4, 2026

Cite this page

510(k) Report. “K840001: Arterial Cannula Straight Beveled Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K840001

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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