510(k) · Cleared
ClearedModification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences Research Medical · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Sep 27, 2006 after a 37-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Sep 27, 2006
- Review
- 37 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK062429 Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium…Edwards Lifesciences Research Medical · 2006
- Descendant · cites it directly · 1 of its ownK141465 Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK182302 CardioGard Emboli Protection CannulaCardiogard Medical, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062429 | Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large… | Edwards Lifesciences Research Medical | 2006 | — |
| +1 | K141465 | Cardiogard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2015 | — |
| +2 | K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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.
Planning a device in DTM? 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 DTM device
- #1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | EMBOL-X Intra-aortic Filters Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141465 | Cardiogard Emboli Protection Cannula | 2015 | 1 |
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?
- Of its descendants, K141465 (Cardiogard Medical, Ltd., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DTM devicesDTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTM
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTM
246in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTM
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTM
4in 2024
MAUDE reports naming product code DTM, 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 | 3 | 60 | 0 | 8 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 5 | 246 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 8 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 27 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EmboI-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062429: Modification to Embol-X Intra-Aortic Filter: X-Small, Small, Medium, Large, X-Large with Heparin Coated Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062429
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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