510(k) · Cleared

Cleared

Edwards Introducer Sheath

K031087510(k) TraditionalCleared Apr 24, 200317-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 Apr 24, 2003 as substantially equivalent to K902469 (Medical Engineering and Development Institute, 1990) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1990. 17 later devices descend from it.

Decided: Apr 24, 2003
Review: 17 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K902469 (1990). 2 ancestors in all. 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK902469 Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
This deviceK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
Descendant · cites it directly · 16 of its ownK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
Descendant · 2 generations on · 8 of its ownK140338 Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus…Creganna-Tactx Medical · 2014
Descendant · 3 generations on · 7 of its ownK180785 iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · Recalled
Descendant · 4 generations on · 4 of its ownK191871 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · Recalled
Descendant · 2 generations on · 4 of its ownK152225 Edwards eSheath Introducer SetEdwards Lifesciences · 2015

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2010high 3 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all

K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010 · cites it directly16descendants
K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical · 2014 · 2 generations on8descendants
K180785iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · 3 generations on7descendants
K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · 4 generations on4descendants
K152225Edwards eSheath Introducer SetEdwards Lifesciences · 2015 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902469	Byrd Dilator Sheath Set - Teflon	Medical Engineering and Development Institute	1990	—
0 (this device)	K031087	Edwards Introducer Sheath	Edwards Lifesciences, LLC	2003	—
+1	K093877	Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26	Edwards Lifesciences, LLC	2010	—
+2	K140338	Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer…	Creganna-Tactx Medical	2014	—
+3	K180785	iSLEEVE Introducer Set	Boston Scientific Corporation	2018	1
+4	K191871	15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set	Boston Scientific Corporation	2019	1
+2	K152225	Edwards eSheath Introducer Set	Edwards Lifesciences	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2014	2	0
2015	2	0
2016	1	0
2018	1	0
2019	2	0
2020	3	0
2023	2	0
2025	3	0

FIG. 1 — Lineage of K031087, 1990–2025Source: 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

Get a 510(k) Report

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
*	K902469	Byrd Dilator Sheath Set - Teflon Summary page 1 …: Class I1 (DYB, 2 1 CFR 870.1340 Catheter introducer) 4. Predicate Device Identification: CookB Extra Large Check-FloB Introducer (K902469) Guidant AncureB Sheath (K003889) 5. Device Description: The subject device is comprised of a…	Medical Engineering and Development Institute	1990	—
*	K003889	Ancure Sheath Model # 40315, 40320, 40325 Summary page 1 …0 Catheter introducer) 4. Predicate Device Identification: CookB Extra Large Check-FloB Introducer (K902469) Guidant AncureB Sheath (K003889) 5. Device Description: The subject device is comprised of an introducer and introducer sheath. The…	Guidant Cardiac and Vascular Surgery	2002	—

Also cleared against K902469: 2 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K093877	Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26	Edwards Lifesciences, LLC	2010	16

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?

None of the 2 ancestors has a recall.
Of its descendants, K093877 (Edwards Lifesciences, LLC, 2010) has gone furthest, with 16 descendants of its own.
2 other devices also cite its predicate K902469.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Introducer Sheath is designed to facilitate the entry of interventional devices into the human vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031087 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031087: Edwards Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031087

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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