510(k) · Cleared

Recalled · Class II · 2019

EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion Cannula

K123370510(k) TraditionalCleared Mar 13, 2013132-day reviewClass II21 CFR 870.4210Recalls 4

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

Edwards Lifesciences, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Mar 13, 2013 as substantially equivalent to K831769 (Research Industries Corp., 1983) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it. It has been recalled 4 times.

Decided: Mar 13, 2013
Review: 132 days
Class: Class II
Product code: DWF
Recalls: 4
Predicates: 2

Its longest line of descent runs back 1 generation to K831769 (1983). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983 · Recalled
This deviceK123370 EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo…Edwards Lifesciences, LLC · 2013
Descendant · cites it directly · 0 of its ownK233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A…Edwards Lifesciences · 2024

Most influential descendants

Showing 1 of 1 · See all

K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…Edwards Lifesciences · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K831769	Various Cardiovascular Surgical Device	Research Industries Corp.	1983	8
0 (this device)	K123370	EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating…	Edwards Lifesciences, LLC	2013	—
+1	K233895	EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A…	Edwards Lifesciences	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K123370, 1983–2024Source: 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? (2)

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
*	K831769	Various Cardiovascular Surgical Device Summary page 1 …ter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass 21 CFR Part 870.4210, Product Code DWF, Class 11 Predicate Device: K831769 - Aortic Perfusion Cannulae K033463 - Aortic Perfusion Pediatric Cannulae Device Description:…	Research Industries Corp.	1983	8
*	K033463	Edwards Lifesciences Research Medical Pediatric Arterial Cannulae Summary page 1 …21 CFR Part 870.4210, Product Code DWF, Class 11 Predicate Device: K831769 - Aortic Perfusion Cannulae K033463 - Aortic Perfusion Pediatric Cannulae Device Description: Edwards Aortic Perfusion Cannulae are sterile, non-pyrogenic, singl…	Edwards Lifesciences, LLC	2004	1

Also cleared against K831769: 3 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
K233895	EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…	Edwards Lifesciences	2024	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 22, 2019	Class II	Z-0420-2020	Under Investigation by firm	Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.
Mar 7, 2018	Class II	Z-3028-2018	Labeling False and Misleading	The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Mar 7, 2018	Class II	Z-3027-2018	Labeling False and Misleading	The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Aug 26, 2013	Class II	Z-0134-2014	Process control	Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K233895 (Edwards Lifesciences, 2024) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K831769.

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. 2013, this device’s year, is highlighted.

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?

Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (5 6 hours) cardiopulmonary bypass procedures.

Aortic Perfusion Cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.

Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123370: EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123370

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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