510(k) · Cleared
ClearedEmbol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cleared on Nov 3, 2003 as substantially equivalent to K022071 (Embol-X, Inc., 2003) and 2 other predicates after a 132-day review. Its family tree reaches back 2 generations to 1982. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 3, 2003
- Review
- 132 days
- Class
- Class II
- Product code
- DTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K820044 (1982). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK820044 Arterial Blood Filter, #AF-1025Bentley Laboratories, Inc. · 1982
- 1 generation backK022071 Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra…Embol-X, Inc. · 2003 · Recalled (Class I)
- This deviceK031946 Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large…Edwards Lifesciences, LLC · 2003
- 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
Class I recalls in this family
- K022071 Embol-X Aortic…direct predicate · 2003
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 |
|---|---|---|---|---|---|
| −2 | K820044 | Arterial Blood Filter, #AF-1025 | Bentley Laboratories, Inc. | 1982 | — |
| −1 | K022071 | Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models… | Embol-X, Inc. | 2003 | Class I |
| 0 (this device) | K031946 | Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large | Edwards Lifesciences, LLC | 2003 | — |
| +1 | K141465 | Cardiogard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2015 | — |
| +2 | K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
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.
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 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? (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 |
|---|---|---|---|
| * | K022071 | Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models…Summary page 2…he Filter Arm of the US IDE Study through analyses of the Composite Safety endpoint as defined in the US IDE Study (K022071). CONFIDENTIAL CONFIDENTIAL CONFIDENTIAL… | 2003 |
| * | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration SystemSummary page 2…ce to the EMBOL-X Aortic Filter (KO22071), the Medtronic Percusurge Guardwire plus temporary occlusion and aspiration system (K003992) and/or the Edwards Lifesciences AF- 1025D/AF- 1040D DURAFLO (heparin treated) arterial… | 2001 |
| * | K820044 | Arterial Blood Filter, #AF-1025Summary page 2…iration system (K003992) and/or the Edwards Lifesciences AF- 1025D/AF- 1040D DURAFLO (heparin treated) arterial blood filter (K820044). Technological The EMBOL-X Intra-aortic Filter has similar intended use, desj gn inteni,… | 1982 |
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? (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.
- K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models CF26000.CF29000,CF32000,CF35000,CF4000Embol-X, Inc. · 2003 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 20.6 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K141465 (Cardiogard Medical, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K022071.
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 EMBOL-X Intra-aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in first time, non-emergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031946: Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031946
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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