510(k) · Cleared

Cleared

Byrd Dilator Sheath Set - Teflon

K902469510(k) TraditionalCleared Aug 23, 199080-day reviewClass II21 CFR 870.1310

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

Medical Engineering and Development Institute · DRE Dilator, Vessel, For Percutaneous Catheterization

Cleared on Aug 23, 1990 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 34 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.

Decided: Aug 23, 1990
Review: 80 days
Class: Class II
Product code: DRE
Recalls: None
Predicates: 0

33 later devices descend from it, 3 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.

This deviceK902469 Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
Descendant · cites it directly · 17 of its ownK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
Descendant · 2 generations on · 16 of its ownK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
Descendant · 3 generations on · 8 of its ownK140338 Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus…Creganna-Tactx Medical · 2014
Descendant · 4 generations on · 7 of its ownK180785 iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · Recalled
Descendant · cites it directly · 7 of its ownK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2003high 4 (2016) · low 0 (2004)2026

Class I recalls in this family

K120212 Afx Introducer System3 generations on · 2012

Most influential descendants

Showing 5 of 33 · See all

K031087Edwards Introducer SheathEdwards Lifesciences, LLC · 2003 · cites it directly17descendants
K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010 · 2 generations on16descendants
K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical · 2014 · 3 generations on8descendants
K180785iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · 4 generations on7descendants
K123990Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013 · cites it directly7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K902469	Byrd Dilator Sheath Set - Teflon	Medical Engineering and Development Institute	1990	—
+1	K031087	Edwards Introducer Sheath	Edwards Lifesciences, LLC	2003	—
+2	K093877	Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26	Edwards Lifesciences, LLC	2010	—
+3	K140338	Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer…	Creganna-Tactx Medical	2014	—
+4	K180785	iSLEEVE Introducer Set	Boston Scientific Corporation	2018	1
+1	K123990	Sentrant Introducer Sheath with Hydrophilic Coating	Medtronic Vascular	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2010	1	0
2011	2	0
2012	1	1
2013	1	0
2014	3	0
2015	3	0
2016	4	0
2017	2	0
2018	2	0
2019	3	0
2020	3	0
2021	1	0
2023	2	0
2025	4	0

FIG. 1 — Lineage of K902469, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 DRE device

#1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (33)

See all 33

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031087	Edwards Introducer Sheath	Edwards Lifesciences, LLC	2003	17
K123990	Sentrant Introducer Sheath with Hydrophilic Coating	Medtronic Vascular	2013	7
K110090	Afx Introducer System	Endologix, Inc.	2011	7

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.

K120212Afx Introducer SystemEndologix, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K031087 (Edwards Lifesciences, LLC, 2003) has gone furthest, with 17 descendants of its own.

How does its category compare?

All DRE devices

DRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRE

3in 2025

2007high 6 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRE

31in 2025

2007high 261 (2022) · low 30 (2015)2026

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

Recalls per year · DRE

1in 2016

2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRE

356in 2025

2007high 386 (2023) · low 38 (2008)2025

MAUDE reports naming product code DRE, 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	5	160	0	81
2008	2	—	0	38
2009	2	—	2	69
2010	1	—	2	73
2011	1	—	1	90
2012	1	—	0	132
2013	4	111	0	120
2014	6	72	0	82
2015	4	30	1	82
2016	3	90	1	84
2017	4	108	0	101
2018	2	—	0	126
2019	3	68	0	144
2020	3	30	0	120
2021	1	—	0	115
2022	3	261	0	136
2023	2	—	0	386
2024	1	—	0	325
2025	3	31	0	356
2026	1	—	1 (1)	—

https://510kreport.com/device/K902469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902469: Byrd Dilator Sheath Set - Teflon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902469

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026