510(k) · Cleared

Cleared

Edwards Embol-X Introducer Sheath

K123714510(k) TraditionalCleared Jul 24, 2013232-day reviewClass II21 CFR 870.1340

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

Edwards Lifesciences, LLC · DYB Introducer, Catheter

Cleared on Jul 24, 2013 as substantially equivalent to K002973 (Embol-X, Inc., 2001) after a 232-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Jul 24, 2013
Review: 232 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002973 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002973 Embol-X Introducer, Model CF00200Embol-X, Inc. · 2001
This deviceK123714 Edwards Embol-X Introducer SheathEdwards Lifesciences, LLC · 2013
Descendant · cites it directly · 0 of its ownK140398 Embol-X Introducer SheathEdwards Lifesciences, LLC · 2014

Most influential descendants

Showing 1 of 1 · See all

K140398Embol-X Introducer SheathEdwards Lifesciences, LLC · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002973	Embol-X Introducer, Model CF00200	Embol-X, Inc.	2001	—
0 (this device)	K123714	Edwards Embol-X Introducer Sheath	Edwards Lifesciences, LLC	2013	—
+1	K140398	Embol-X Introducer Sheath	Edwards Lifesciences, LLC	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K123714, 2001–2014Source: 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 DYB? 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 DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 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
*	K002973	Embol-X Introducer, Model CF00200 Summary page 1 …: Introducer, Catheter, Cardiovascular Devices Panel; 21 CIFR §870.1340 Product Code DYB, Class 11 Predicate Device: K002973, EMBOL-X Introducer Device Description: Edwards Lifesciences' EMBOL-X Introducer Sheath is a sterile, non-pyrogenic, single- u…	Embol-X, Inc.	2001	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140398	Embol-X Introducer Sheath	Edwards Lifesciences, LLC	2014	0

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?

Its one ancestor has no recall.
Of its descendants, K140398 (Edwards Lifesciences, LLC, 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123714 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123714: Edwards Embol-X Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123714

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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