510(k) · Cleared
Recalled · Class I · 202518 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences Research Medical · DQR Cannula, Catheter
Cleared on Jan 31, 2008 after a 43-day review. The FDA summary names its predicate without a number. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Jan 31, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- DQR
- Recalls
- 3 (2 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK073559 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial…Edwards Lifesciences Research Medical · 2008
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K073559 | 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion… | Edwards Lifesciences Research Medical | 2008 | — |
| +1 | K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A… | Edwards Lifesciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 | Decided |
|---|---|---|---|
| * | — | Edwards Lifesciences Arterial Perfusion Cannula Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA… | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2025 | Class I | Z-2081-2025 | Under Investigation by firm | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| May 14, 2025 | Class I | Z-2080-2025 | Under Investigation by firm | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| Mar 7, 2018 | Class II | Z-3034-2018 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K233895 (Edwards Lifesciences, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQR devicesDQR Cannula, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQR
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DQR
Too few DQR 510(k)s in any year since 2007 to give a median.
Recalls per year · DQR
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQR
6in 2025
MAUDE reports naming product code DQR, 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 | 0 | — | 0 | 17 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 27 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 75 |
| 2017 | 0 | — | 0 | 29 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 1 | 4 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for <6 hours. Cannulation site is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073559 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073559: 18 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073559
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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