510(k) · Cleared

Cleared

Prelude 7F Short Sheath Introducer

K122190510(k) SpecialCleared Aug 17, 201224-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

Merit Medical Systems, Inc. · DYB Introducer, Catheter

Cleared on Aug 17, 2012 as substantially equivalent to K082063 (Merit Medical Systems, Inc., 2008) after a 24-day review. Its family tree reaches back 2 generations to 1996. 1 of the 3 devices in its family, counting itself, has a Class I recall.

Decided: Aug 17, 2012
Review: 24 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K961780 (1996). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK961780 Hemodialysis Introducer SetThomas Medical Products, Inc. · 1996
1 generation backK082063 Prelude Short Sheath IntroducerMerit Medical Systems, Inc. · 2008 · Recalled (Class I)
This deviceK122190 Prelude 7F Short Sheath IntroducerMerit Medical Systems, Inc. · 2012

Class I recalls in this family

K082063 Prelude Short Sheath Introducerdirect predicate · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961780	Hemodialysis Introducer Set	Thomas Medical Products, Inc.	1996	—
−1	K082063	Prelude Short Sheath Introducer	Merit Medical Systems, Inc.	2008	Class I
0 (this device)	K122190	Prelude 7F Short Sheath Introducer	Merit Medical Systems, Inc.	2012	—

FIG. 1 — Lineage of K122190, 1996–2012Source: 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.

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 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? (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
*	K082063	Prelude Short Sheath Introducer Summary page 1 …Trade Name: Prelude® Short Sheath Introducer Predicate Classification Name: Introducer, Catheter Device Premarket Notification: K082063 Manufacturer: Merit Medical Systems, Inc. Class 11 Classification 21…	Merit Medical Systems, Inc.	2008	Class I

What descends from it?

No later submission names this one as a predicate yet.

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.

K082063Prelude Short Sheath IntroducerMerit Medical Systems, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

The Prelude@ 7F Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a Variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122190 · printed Nov 4, 2026

Cite this page

510(k) Report. “K122190: Prelude 7F Short Sheath Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122190

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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