510(k) · Cleared

Recalled · Class II · 2016

2F & 3F Vascu-Sheath Tearaway Introducer

K130687510(k) TraditionalCleared Aug 15, 2013155-day reviewClass II21 CFR 870.1340Recalls 1

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

Medical Components, Inc. · DYB Introducer, Catheter

Cleared on Aug 15, 2013 as substantially equivalent to K053092 (Medcomp, 2006) after a 155-day review. Its family tree reaches back 3 generations to 2000. It has been recalled once.

Decided: Aug 15, 2013
Review: 155 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K993191 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK993191 TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000
2 generations backK022513 Medcomp Vascu-Sheath Introducer SetMedcomp · 2002
1 generation backK053092 Medcomp Vascu-Sheath IIMedcomp · 2006
This deviceK130687 2F & 3F Vascu-Sheath Tearaway IntroducerMedical Components, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K993191	TFX Medical Introducer Assembly	Tfx Medical, Inc.	2000	—
−2	K022513	Medcomp Vascu-Sheath Introducer Set	Medcomp	2002	—
−1	K053092	Medcomp Vascu-Sheath II	Medcomp	2006	—
0 (this device)	K130687	2F & 3F Vascu-Sheath Tearaway Introducer	Medical Components, Inc.	2013	—

FIG. 1 — Lineage of K130687, 2000–2013Source: 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
*	K053092	Medcomp Vascu-Sheath II Summary page 1 …ion: 870.1340 Class: 11 C. Predicate Device: K053092 Medcomp, Vason-Sheath 11 D. Device Description: The Medeomp 2…	Medcomp	2006	—

Also cleared against K053092: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 5, 2016	Class II	Z-1924-2016	Labeling mix-ups	This recall has been initiated due to the product labeled with the incorrect expiration date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K053092.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130687 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130687: 2F & 3F Vascu-Sheath Tearaway Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130687

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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