510(k) · Cleared

Recalled · 2010

Tear-Away Sheath Introducer Set with Integral Hemostasis Valve

K934901510(k) TraditionalCleared Jan 21, 199499-day reviewClass II21 CFR 870.1340Recalls 7

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

Thomas Medical Products, Inc. · DYB Introducer, Catheter

Cleared on Jan 21, 1994 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 7 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 7 times.

Decided: Jan 21, 1994
Review: 99 days
Class: Class II
Product code: DYB
Recalls: 7
Predicates: 0

6 later devices descend from it, 3 citing it directly. 4 of the 7 devices in this family, counting this one, have a Class I recall.

This deviceK934901 Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. · 1994
Descendant · cites it directly · 2 of its ownK122084 Introducer Set, Model Adelante-S SeriesOscor, Inc. · 2012 · Recalled (Class I)
Descendant · cites it directly · 1 of its ownK143255 Prelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc. · 2015 · Recalled
Descendant · 2 generations on · 0 of its ownK201116 Abiomed 23 Fr SheathAbiomed, Inc. · 2020 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK192769 Impella CP IntroducerAbiomed, Inc. · 2019 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK152381 Prelude SNAP Splittable Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005high 2 (2015) · low 0 (2006)2026

Class I recalls in this family

K122084 Introducer Set, Model Adelante-S Seriescites it directly · 2012
K043438 Large Bore Splittable Introducer Kitcites it directly · 2005
K192769 Impella CP Introducer2 generations on · 2019
K201116 Abiomed 23 Fr Sheath2 generations on · 2020

Most influential descendants

Showing 5 of 6 · See all

K122084Introducer Set, Model Adelante-S SeriesOscor, Inc. · 2012 · cites it directly2descendants
K143255Prelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc. · 2015 · cites it directly1descendant
K201116Abiomed 23 Fr SheathAbiomed, Inc. · 2020 · 2 generations on0descendants
K192769Impella CP IntroducerAbiomed, Inc. · 2019 · 2 generations on0descendants
K152381Prelude SNAP Splittable Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K934901	Tear-Away Sheath Introducer Set with Integral Hemostasis Valve	Thomas Medical Products, Inc.	1994	—
+1	K122084	Introducer Set, Model Adelante-S Series	Oscor, Inc.	2012	Class I
+1	K143255	Prelude SNAP Splittable Sheath Introducer	Merit Medical Systems, Inc.	2015	4
+2	K201116	Abiomed 23 Fr Sheath	Abiomed, Inc.	2020	Class I
+2	K192769	Impella CP Introducer	Abiomed, Inc.	2019	Class I
+2	K152381	Prelude SNAP Splittable Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	2015	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	1
2012	1	1
2015	2	0
2019	1	1
2020	1	1

FIG. 1 — Lineage of K934901, 1994–2020Source: 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.

4 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.

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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K122084	Introducer Set, Model Adelante-S Series Class I	Oscor, Inc.	2012	2
K143255	Prelude SNAP Splittable Sheath Introducer	Merit Medical Systems, Inc.	2015	1
K043438	Large Bore Splittable Introducer Kit Class I	Thomas Medical Products, Inc.	2005	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 16, 2010	Not classified	Z-1226-2011	Packaging process control	Compromised sterility/weak or open seals.
Dec 16, 2010	Not classified	Z-1225-2011	Packaging process control	Compromised sterility/weak or open seals.
Dec 16, 2010	Not classified	Z-1228-2011	Packaging process control	Compromised sterility/weak or open seals.
Oct 1, 2008	Not classified	Z-0280-2009	Process control	Failure to insert the guidewire through the introducer needle.
Sep 12, 2008	Not classified	Z-0131-2009	Process control	Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
Nov 7, 2005	Not classified	Z-0297-06	Other	mislabeled as 9.5F actually contains 10.5F
Oct 14, 2004	Not classified	Z-0056-05	Other	Sheaths may fracture if exposed to excess fluorescent light

The 5 latest of 7 recalls; the web page lists all.

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.

K122084Introducer Set, Model Adelante-S SeriesOscor, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
K043438Large Bore Splittable Introducer KitThomas Medical Products, Inc. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K192769Impella CP IntroducerAbiomed, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
K201116Abiomed 23 Fr SheathAbiomed, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 113 Class I recalls

What does this lineage say?

Of its descendants, K122084 (Oscor, Inc., 2012) has gone furthest, with 2 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.

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)	—

https://510kreport.com/device/K934901 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934901: Tear-Away Sheath Introducer Set with Integral Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934901

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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