510(k) · Cleared
ClearedEZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Feb 5, 2024 as substantially equivalent to K123370 (Edwards Lifesciences, LLC, 2013) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1983. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 5, 2024
- Review
- 56 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K831769 (1983). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK831769 Various Cardiovascular Surgical DeviceResearch Industries Corp. · 1983 · Recalled
- 1 generation backK123370 EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo…Edwards Lifesciences, LLC · 2013 · Recalled
- This deviceK233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A…Edwards Lifesciences · 2024
Class I recalls in this family
- K073559 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR.…direct predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831769 | Various Cardiovascular Surgical Device | Research Industries Corp. | 1983 | 8 |
| −1 | K123370 | EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating… | Edwards Lifesciences, LLC | 2013 | 4 |
| 0 (this device) | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 1 |
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
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 | Decided |
|---|---|---|---|
| * | K123370 | EZ Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion…Summary page 6…ted Predicate Devices Predicate # Predicate Trade Name (Primary Product Code Predicate is listed first) K123370 EZ Glide Aortic Perfusion Cannulae DWF K073559 OptiSite Arterial Perfusion… | 2013 |
| * | K073559 | 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula IISummary page 6…(Primary Product Code Predicate is listed first) K123370 EZ Glide Aortic Perfusion Cannulae DWF K073559 OptiSite Arterial Perfusion Cannulae DWF K971291 EndoReturn Arterial Cannulae… | 2008 |
| * | K971291 | Heartport Endoarterial Return CannulaSummary page 6…listed first) K123370 EZ Glide Aortic Perfusion Cannulae DWF K073559 OptiSite Arterial Perfusion Cannulae DWF K971291 EndoReturn Arterial Cannulae DWF Device Description Summary EZ Glide Aortic Perfusion Cannu… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K07355918 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula IIEdwards Lifesciences Research Medical · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 41 years and passes through 3 companies; a new generation was cleared every 29.6 years on median.
- 5 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 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?
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for < 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch. The EndoReturn arterial cannula are indicated for patients undergoing cardiopulmonary bypass. They are intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The EndoReturn…
Read the full statement (135 words)
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for < 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
The EndoReturn arterial cannula are indicated for patients undergoing cardiopulmonary bypass. They are intended to deliver oxygenated blood for cardiopulmonary bypass during surgery.
The EndoReturn arterial cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the EndoClamp aortic catheter.
Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233895: EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233895
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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