510(k) · Cleared
ClearedDuraGraft Vascular Conduit Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marizyme · QEJ Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
Cleared on May 1, 2024 as substantially equivalent to DEN230002 (Marizyme, Inc., 2023) after a 27-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- May 1, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- QEJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230002 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230002 DuraGraftMarizyme, Inc. · 2023
- This deviceK240925 DuraGraft Vascular Conduit SolutionMarizyme · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230002 | DuraGraft | Marizyme, Inc. | 2023 | — |
| 0 (this device) | K240925 | DuraGraft Vascular Conduit Solution | Marizyme | 2024 | — |
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 QEJ? 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 |
|---|---|---|---|
| * | DEN230002 | DuraGraftSummary page 4…oronary Artery Bypass Graft Surgeries Regulatory Class: Class II Regulation: 21 CFR 876.4100 Product Code: QEJ Predicate Device: DuraGraft Vascular Conduit Solution (DEN230002) Device Description DuraGraft Vascular Conduit Solution is a single-use, clear, colorless to slightly yellow, non-pyrogenic sol… | 2023 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QEJ devicesQEJ Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QEJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEJ
Too few QEJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QEJ
No recall names QEJ since 2007.
Adverse event reports per year · QEJ
No MAUDE report names QEJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Grafting Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240925 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240925: DuraGraft Vascular Conduit Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240925
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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