510(k) · Cleared

Cleared

Embol-X Aortic Occlusion and Cardioplegia Cannula

K980631510(k) TraditionalCleared Feb 2, 1999349-day reviewClass II21 CFR 870.4450

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

Cleared on Feb 2, 1999 as substantially equivalent to K962510 (Heartport, Inc., 1996) and 3 other predicates after a 349-day review. Its family tree reaches back 1 generation to 1979.

Decided: Feb 2, 1999
Review: 349 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K790565 (1979). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK790565 Aortic Root CannulaDlp, Inc. · 1979 · Recalled
This deviceK980631 Embol-X Aortic Occlusion and Cardioplegia CannulaEmbol-X, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K790565	Aortic Root Cannula	Dlp, Inc.	1979	1
0 (this device)	K980631	Embol-X Aortic Occlusion and Cardioplegia Cannula	Embol-X, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1990	1	0
1996	1	0

FIG. 1 — Lineage of K980631, 1979–1999Source: 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.

Planning a device in DXC? 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K962510	Heartport Endoaortic Clamp Summary page 2 …ssification Name Cardiopulmonary Bypass Vascular Cannula. 21 C.F.R. § 870.4210; Vascular Clamp, 21 C.F.R. § 870.4450 Predicate Devices ) Heartport’s Endoaortic Clamp (K962510) ) Datascope’s Precluder DL Occluding Balloon (K832356) ) Medtronic’s DLP - Aortic Root Cannula (K790565) 4) RMI’s Anteplegia C…	Heartport, Inc.	1996	2
*	K832386	Percluder DL Occluding Balloon Our OCR of the scanned summary read K832356, FDA’s number for Portable Operat. RM. Monitors HS30/40 (Medtel Pty., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Datascope’s Precluder DL Occluding Balloon”.	Datascope Corp.	1983	—
*	K790565	Aortic Root Cannula Summary page 2 …§ 870.4450 Predicate Devices ) Heartport’s Endoaortic Clamp (K962510) ) Datascope’s Precluder DL Occluding Balloon (K832356) ) Medtronic’s DLP - Aortic Root Cannula (K790565) 4) RMI’s Anteplegia Cannula (K896636) (1 (2 3 ( V. Intended Use/Indications The EMBOL-X Aortic Occlusion and…	Dlp, Inc.	1979	1
*	K896636	Rmi Anteplegia Cannula Summary page 2 …port’s Endoaortic Clamp (K962510) ) Datascope’s Precluder DL Occluding Balloon (K832356) ) Medtronic’s DLP - Aortic Root Cannula (K790565) 4) RMI’s Anteplegia Cannula (K896636) (1 (2 3 ( V. Intended Use/Indications The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended for us…	Research Medical, Inc.	1990	—

Also cleared against K962510: 1 other device →

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?

2 of the 4 ancestors have a recall of any class.
1 other device also cites its predicate K962510.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended

for use during cardiopulmonary bypass (CPB) procedures to: (1) occlude the

ascending aorta, (2) deliver cardioplegia solution, and (3) vent the aortic root.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980631: Embol-X Aortic Occlusion and Cardioplegia Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980631

Report an extraction error

Are you the manufacturer?

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