510(k) · Cleared

Recalled · Class I · 2019

IntraClude Intra-Aortic Occlusion Device

K163693510(k) SpecialCleared Jan 26, 201729-day reviewClass II21 CFR 870.4450Recalls 3 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edwards Lifesciences, LLC · DXC Clamp, Vascular

Cleared on Jan 26, 2017 as substantially equivalent to K132175 (Edwards Lifesciences, LLC, 2013) after a 29-day review. Its family tree reaches back 1 generation to 2013. 2 of the 2 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times, including a Class I recall.

Decided: Jan 26, 2017
Review: 29 days
Class: Class II
Product code: DXC
Recalls: 3 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K132175 (2013). No later device cites it as a predicate yet. 2 of the 2 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK132175 Edwards Lifesciences Intraclude Intra-Aortic CatheterEdwards Lifesciences, LLC · 2013 · Recalled (Class I)
This deviceK163693 IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC · 2017

Class I recalls in this family

K132175 Edwards Lifesciences Intraclude Intra-Aortic…direct predicate · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K132175	Edwards Lifesciences Intraclude Intra-Aortic Catheter	Edwards Lifesciences, LLC	2013	Class I
0 (this device)	K163693	IntraClude Intra-Aortic Occlusion Device	Edwards Lifesciences, LLC	2017	—

FIG. 1 — Lineage of K163693, 2013–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K132175	Edwards Lifesciences Intraclude Intra-Aortic Catheter Summary page 4 …cclusion Device Classification Vascular Clamp Name: 21 CFR Part 870.4450, Product Code DXC, Class II Predicate Device: K132175 IntraClude™ Intra-Aortic Occlusion Device Device Description: The IntraClude Intra-Aortic Occlusion Device (model code I…	Edwards Lifesciences, LLC	2013	Class I

What descends from it?

No later submission names this one as a predicate yet.

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…
Jan 16, 2019	Class II	Z-1100-2019	Process control	Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
Mar 30, 2018	Class II	Z-1929-2018	Under Investigation by firm	Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

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.

K132175Edwards Lifesciences Intraclude Intra-Aortic CatheterEdwards Lifesciences, LLC · 2013 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall, Class I.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · DXC

2in 2025

2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007high 215 (2023) · low 29 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXC

2in 2023

2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007high 920 (2013) · low 273 (2022)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 device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion device 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/K163693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163693: IntraClude Intra-Aortic Occlusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163693

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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