PMA · Approved
ApprovedCarpentier-Edwards S.a.V. Bioprosthesis, Model 2650 (Aortic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DYE Replacement Heart-Valve
Approved on Jun 24, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 327-day review.
- Decided
- Jun 24, 2002
- Review
- 327 days
- Class
- Class III
- Product code
- DYE
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010041 has 49 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 6 |
| 2007 | 3 |
| 2008 | 5 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 10 |
| 2013 | 8 |
| 2014 | 4 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYE? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All DYE devicesDYE Replacement Heart-Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYE
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYE
Too few DYE 510(k)s in any year since 2007 to give a median.
Recalls per year · DYE
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYE
3,106in 2025
MAUDE reports naming product code DYE, 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 | 28 | — | 0 | 19 |
| 2008 | 34 | — | 0 | 16 |
| 2009 | 31 | — | 2 | 910 |
| 2010 | 47 | — | 0 | 1,071 |
| 2011 | 22 | — | 0 | 1,221 |
| 2012 | 58 | — | 0 | 1,015 |
| 2013 | 66 | — | 0 | 1,219 |
| 2014 | 38 | — | 0 | 1,282 |
| 2015 | 13 | — | 0 | 1,242 |
| 2016 | 22 | — | 0 | 1,744 |
| 2017 | 34 | — | 0 | 2,284 |
| 2018 | 27 | — | 0 | 3,166 |
| 2019 | 16 | — | 0 | 2,820 |
| 2020 | 13 | — | 0 | 2,466 |
| 2021 | 7 | — | 0 | 2,833 |
| 2022 | 8 | — | 0 | 2,566 |
| 2023 | 11 | — | 0 | 3,489 |
| 2024 | 7 | — | 0 | 3,435 |
| 2025 | 13 | — | 0 | 3,106 |
| 2026 | 7 | — | 0 | — |
https://510kreport.com/device/P010041 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010041: Carpentier-Edwards S.a.V. Bioprosthesis, Model 2650 (Aortic).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010041
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026