510(k) · Cleared

Cleared

Madtronic DLP Arterial Cannulae

K991066510(k) TraditionalCleared Sep 14, 1999167-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 Vascular · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Sep 14, 1999 as substantially equivalent to K880421 (Dlp, Inc., 1988) after a 167-day review. Its family tree reaches back 1 generation to 1988. 12 later devices descend from it.

Decided: Sep 14, 1999
Review: 167 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K880421 (1988). 12 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK880421 Descending Arch CannulaDlp, Inc. · 1988
This deviceK991066 Madtronic DLP Arterial CannulaeMedtronic Vascular · 1999
Descendant · cites it directly · 11 of its ownK031037 Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · Recalled
Descendant · 2 generations on · 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
Descendant · 3 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 ownK110980 Centrimag Return Cannula KitLevitronix, LLC · 2011

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all

K031037Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003 · cites it directly11descendants
K031518Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…Medtronic Vascular · 2003 · 2 generations on6descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
K110980Centrimag Return Cannula KitLevitronix, LLC · 2011 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K880421	Descending Arch Cannula	Dlp, Inc.	1988	—
0 (this device)	K991066	Madtronic DLP Arterial Cannulae	Medtronic Vascular	1999	—
+1	K031037	Eopa Elongated One-Piece Arterial Cannula and Guidewire	Medtronic Perfusion Systems	2003	6
+2	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	—
+3	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+2	K110980	Centrimag Return Cannula Kit	Levitronix, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2011	2	0
2012	1	0
2014	1	0
2015	1	0
2020	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K991066, 1988–2026Source: 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
*	K880421	Descending Arch Cannula Summary page 1 …nary bypass vascular cannula”, Class IX at 27 CFR 870.4210 Predicate Substantially Equivalent Device: Medtronic DLP Arterial Cannula Family, Cleared under 510(k) Number K880421 on April 28, 1988, Class Il at 21 CFR 870.4210 Description of Device: These Medtronic DLP Arterial Cannulae feature a thin-wall…	Dlp, Inc.	1988	—

What descends from it? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031037	Eopa Elongated One-Piece Arterial Cannula and Guidewire	Medtronic Perfusion Systems	2003	11

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?

Its one ancestor has no recall.
Of its descendants, K031037 (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	—

What is it indicated for?

This product is intended for use with cardiopulmonary bypass as

an arterial return cannula.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991066: Madtronic DLP Arterial Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991066

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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