510(k) · Cleared

Cleared

Pediatric Aortic Root Cannula

K040173510(k) SpecialCleared Mar 19, 200453-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 Perfusion Systems · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Mar 19, 2004 as substantially equivalent to K790565 (Dlp, Inc., 1979) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1979. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Mar 19, 2004
Review: 53 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K790565 (1979). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK790565 Aortic Root CannulaDlp, Inc. · 1979 · Recalled
This deviceK040173 Pediatric Aortic Root CannulaMedtronic Perfusion Systems · 2004
Descendant · cites it directly · 0 of its ownK100274 Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard…Medtronic, Inc. · 2010 · Recalled (Class I)

Class I recalls in this family

K100274 Miar (Minimally Invasive Aortic Root) Cannula…cites it directly · 2010

Most influential descendants

Showing 1 of 1 · See all

K100274Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014LMedtronic, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K790565	Aortic Root Cannula	Dlp, Inc.	1979	1
0 (this device)	K040173	Pediatric Aortic Root Cannula	Medtronic Perfusion Systems	2004	—
+1	K100274	Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L…	Medtronic, Inc.	2010	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	1

FIG. 1 — Lineage of K040173, 1979–2010Source: 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.

1 device in this family has a Class I recall. 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? (3)

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
*	K790565	Aortic Root Cannula Summary page 1 …tubing Classification: Class II Predicate Devices: Aortic Root Cannulae K790565, K810548, K831591 Device Description: The new Pediatric Aortic Root Cannula has a soft, flexible, thin wall, radi…	Dlp, Inc.	1979	1
*	K810548	Cardiopulminary Bypass Catheter Cannula Summary page 1 …Classification: Class II Predicate Devices: Aortic Root Cannulae K790565, K810548, K831591 Device Description: The new Pediatric Aortic Root Cannula has a soft, flexible, thin wall, radiopaque ti…	Dlp, Inc.	1981	—
*	K831591	Aortic Root Cannula W/Integral Press Summary page 1 …Classification: Class II Predicate Devices: Aortic Root Cannulae K790565, K810548, K831591 Device Description: The new Pediatric Aortic Root Cannula has a soft, flexible, thin wall, radiopaque tip with a…	Dlp, Inc.	1983	2

Also cleared against K790565: 7 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K100274	Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L Class I	Medtronic, Inc.	2010	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K100274Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014LMedtronic, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K100274 (Medtronic, Inc., 2010) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K790565.

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 cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040173: Pediatric Aortic Root Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040173

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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