510(k) · Cleared
Recalled · Class I · 2019Edwards Lifesciences Intraclude Intra-Aortic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXC Clamp, Vascular
Cleared on Sep 13, 2013 after a 60-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 of the 2 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Sep 13, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 2 (1 Class I)
- Predicates
- 1
1 later device descends from it, 1 citing it directly. 2 of the 2 devices in this family, counting this one, have a Class I recall.
- This deviceK132175 Edwards Lifesciences Intraclude Intra-Aortic CatheterEdwards Lifesciences, LLC · 2013
- Descendant · cites it directly · 0 of its ownK163693 IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC · 2017 · Recalled (Class I)
Class I recalls in this family
- K163693 IntraClude Intra-Aortic Occlusion Devicecites it directly · 2017
Most influential descendants
Showing 1 of 1 · See all- K163693IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132175 | Edwards Lifesciences Intraclude Intra-Aortic Catheter | Edwards Lifesciences, LLC | 2013 | — |
| +1 | K163693 | IntraClude Intra-Aortic Occlusion Device | Edwards Lifesciences, LLC | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 1 |
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.
2 devices in this family have 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K131182 | FDA’s K131182 is Multifix S Knotless Fixation Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2013 |
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 |
|---|---|---|---|
| K163693 | IntraClude Intra-Aortic Occlusion Device Class I | 2017 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2019 | Class I | Z-1705-2019 | Device Design | Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative… |
| May 5, 2015 | Class II | Z-1758-2015 | Device Design | Potential device damage on the strain relief near the hub area, which may result in blood leakage. |
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.
- K163693IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K163693 (Edwards Lifesciences, LLC, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The IntraClude intra-Aortic Occlusion Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132175 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132175: Edwards Lifesciences Intraclude Intra-Aortic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132175
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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