510(k) · Cleared

Cleared

Gore Introducer Sheath

K013282510(k) TraditionalCleared Dec 14, 200173-day reviewClass I21 CFR 866.5520

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

W. L. Gore & Associates, Inc. · DBY Fab, Rhodamine, Antigen, Antiserum, Control

Cleared on Dec 14, 2001 after a 73-day review. The FDA summary names its predicate without a number. 2 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.

Decided: Dec 14, 2001
Review: 73 days
Class: Class I
Product code: DBY
Recalls: None
Predicates: 0

33 later devices descend from it, 1 citing it directly. 2 of the 34 devices in this family, counting this one, have a Class I recall.

This deviceK013282 Gore Introducer SheathW. L. Gore & Associates, Inc. · 2001
Descendant · cites it directly · 32 of its ownK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
Descendant · 2 generations on · 18 of its ownK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
Descendant · 2 generations on · 9 of its ownK160254 GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · Recalled
Descendant · 2 generations on · 7 of its ownK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013
Descendant · 3 generations on · 5 of its ownK212392 Intri24 SheathInari Medical, Inc. · 2022

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2010high 5 (2016) · low 0 (2011)2026

Class I recalls in this family

K152498 SoloPath Re-Collapsible Access System3 generations on · 2016
K241708 Abiomed 14Fr Low Profile Introducer Kit4 generations on · 2024

Most influential descendants

Showing 5 of 33 · See all

K093791Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010 · cites it directly32descendants
K121234Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012 · 2 generations on18descendants
K160254GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · 2 generations on9descendants
K123990Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013 · 2 generations on7descendants
K212392Intri24 SheathInari Medical, Inc. · 2022 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013282	Gore Introducer Sheath	W. L. Gore & Associates, Inc.	2001	—
+1	K093791	Gore Dryseal Sheath	W. L. Gore & Associates, Inc.	2010	—
+2	K121234	Gore (R) Dryseal Sheath with Hydrophilic Coating	W. L. Gore & Associates, Inc.	2012	—
+2	K160254	GORE DrySeal Flex Introducer Sheath	W. L. Gore & Associates, Inc.	2016	1
+2	K123990	Sentrant Introducer Sheath with Hydrophilic Coating	Medtronic Vascular	2013	—
+3	K212392	Intri24 Sheath	Inari Medical, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	2	0
2013	2	0
2014	2	0
2015	1	0
2016	5	1
2017	2	0
2019	2	0
2021	2	0
2022	2	0
2023	3	0
2024	1	1
2025	5	0
2026	3	0

FIG. 1 — Lineage of K013282, 2001–2026Source: 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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
*	—	FAST-CATH™ Hemostasis Introducer Named without a submission number			—

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K093791	Gore Dryseal Sheath	W. L. Gore & Associates, Inc.	2010	32

Has anything in its family been recalled? (2 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.

K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

Of its descendants, K093791 (W. L. Gore & Associates, Inc., 2010) has gone furthest, with 32 descendants of its own.

How does its category compare?

All DBY devices

DBY Fab, Rhodamine, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DBY

FDA has decided no DBY device since 2007.

Median 510(k) review, days · DBY

Too few DBY 510(k)s in any year since 2007 to give a median.

Recalls per year · DBY

No recall names DBY since 2007.

Adverse event reports per year · DBY

1in 2007

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code DBY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The GORE®Introducer Sheath is used to facilitate the introduction

of guidewires, catheters and other interventional medical devices

into the vasculature, and to minimize blood loss associated with

such introduction.

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/K013282 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013282: Gore Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013282

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026