510(k) · Cleared

Recalled · Class II · 2024

Prelude SNAP Splittable Sheath Introducer

K143255510(k) TraditionalCleared Apr 9, 2015147-day reviewClass II21 CFR 870.1340Recalls 4

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

Merit Medical Systems, Inc. · DYB Introducer, Catheter

Cleared on Apr 9, 2015 as substantially equivalent to K934901 (Thomas Medical Products, Inc., 1994) after a 147-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled 4 times.

Decided: Apr 9, 2015
Review: 147 days
Class: Class II
Product code: DYB
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K934901 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK934901 Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. · 1994 · Recalled
This deviceK143255 Prelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc. · 2015
Descendant · cites it directly · 0 of its ownK152381 Prelude SNAP Splittable Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K152381Prelude SNAP Splittable Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934901	Tear-Away Sheath Introducer Set with Integral Hemostasis Valve	Thomas Medical Products, Inc.	1994	7
0 (this device)	K143255	Prelude SNAP Splittable Sheath Introducer	Merit Medical Systems, Inc.	2015	—
+1	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
2015	1	0

FIG. 1 — Lineage of K143255, 1994–2015Source: 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.

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

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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
*	K934901	Tear-Away Sheath Introducer Set with Integral Hemostasis Valve Summary page 4 …Introducer System Classification Name: Introducer, Catheter (21 CFR §870.1340) Premarket Notification: K934901 – Tear-Away Sheath Introducer Predicate Set With Integral Hemostasis Valve Dev…	Thomas Medical Products, Inc.	1994	7

Also cleared against K934901: 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
K152381	Prelude SNAP Splittable Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	2015	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 11, 2024	Class II	Z-2574-2024	No Marketing Application	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Jun 30, 2021	Class II	Z-2239-2021	Packaging process control	There is a potential that 7F sheaths are packaged as 10F sheaths.
Jun 30, 2021	Class II	Z-2238-2021	Packaging process control	There is a potential that 7F sheaths are packaged as 10F sheaths.
Dec 14, 2017	Class II	Z-0688-2018	Under Investigation by firm	Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K152381 (Merit Medical Systems, Inc., 2015) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K934901.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

For the introduction of various types of pacing leads and catheters to the heart and coronary venous system

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143255 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143255: Prelude SNAP Splittable Sheath Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143255

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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