510(k) · Cleared

Cleared

Edwards Esheath Introducer Set

K141696510(k) TraditionalCleared Sep 18, 201486-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 · DYB Introducer, Catheter

Cleared on Sep 18, 2014 as substantially equivalent to K093877 (Edwards Lifesciences, LLC, 2010) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1990. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Sep 18, 2014
Review: 86 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K902469 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK902469 Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
2 generations backK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
1 generation backK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
This deviceK141696 Edwards Esheath Introducer SetEdwards Lifesciences · 2014
Descendant · cites it directly · 0 of its ownK152054 Confida Adaptive SheathMedtronic, Inc. · 2015

Class I recalls in this family

K100819 The Solopath Balloon Expandable Transfemoral…direct predicate · 2010

Most influential descendants

Showing 1 of 1 · See all

K152054Confida Adaptive SheathMedtronic, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K902469	Byrd Dilator Sheath Set - Teflon	Medical Engineering and Development Institute	1990	—
−2	K031087	Edwards Introducer Sheath	Edwards Lifesciences, LLC	2003	—
−1	K093877	Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26	Edwards Lifesciences, LLC	2010	—
0 (this device)	K141696	Edwards Esheath Introducer Set	Edwards Lifesciences	2014	—
+1	K152054	Confida Adaptive Sheath	Medtronic, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2009	1	0
2010	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K141696, 1990–2015Source: 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.

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 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? (2)

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
*	K093877	Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 Summary page 4 …, Introducer Classification: Catheter Introducer 21 CFR 870.1340, Product Code DYB Predicate RetroFlex 3 Introducer Sheath Set (K093877) Devices: Solopath Balloon Expandable Transfemoral Introducer (K100819) Device Description: The Edwards eSheath Int…	Edwards Lifesciences, LLC	2010	—
*	K100819	The Solopath Balloon Expandable Transfemoral Introducer Summary page 4 …870.1340, Product Code DYB Predicate RetroFlex 3 Introducer Sheath Set (K093877) Devices: Solopath Balloon Expandable Transfemoral Introducer (K100819) Device Description: The Edwards eSheath Introducer Set consists of a sheath, introducer, and loader. It is provided sterile for…	Onset Medical Corporation	2010	Class I

Also cleared against K093877: 2 other devices →

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
K152054	Confida Adaptive Sheath	Medtronic, Inc.	2015	0

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.

K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K152054 (Medtronic, Inc., 2015) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K093877.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Edwards eSheath Introducer Set is indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141696 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141696: Edwards Esheath Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141696

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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