510(k) · Cleared

Cleared

Medcomp Vascu-Sheath Introducer Set

K022513510(k) TraditionalCleared Oct 25, 200287-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

Medcomp · DYB Introducer, Catheter

Cleared on Oct 25, 2002 as substantially equivalent to K993191 (Tfx Medical, Inc., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 16 later devices descend from it.

Decided: Oct 25, 2002
Review: 87 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993191 (2000). 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK993191 TFX Medical Introducer AssemblyTfx Medical, Inc. · 2000
This deviceK022513 Medcomp Vascu-Sheath Introducer SetMedcomp · 2002
Descendant · cites it directly · 14 of its ownK053092 Medcomp Vascu-Sheath IIMedcomp · 2006
Descendant · 2 generations on · 12 of its ownK090394 Valved Tearway IntroducerMedcomp · 2009
Descendant · 3 generations on · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
Descendant · 4 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
Descendant · 2 generations on · 2 of its ownK120617 Ptfe Super Sheath IntroducerMartech Medical Products · 2012

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2006high 3 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 16 · See all

K053092Medcomp Vascu-Sheath IIMedcomp · 2006 · cites it directly14descendants
K090394Valved Tearway IntroducerMedcomp · 2009 · 2 generations on12descendants
K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · 3 generations on4descendants
K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 4 generations on2descendants
K120617Ptfe Super Sheath IntroducerMartech Medical Products · 2012 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993191	TFX Medical Introducer Assembly	Tfx Medical, Inc.	2000	—
0 (this device)	K022513	Medcomp Vascu-Sheath Introducer Set	Medcomp	2002	—
+1	K053092	Medcomp Vascu-Sheath II	Medcomp	2006	—
+2	K090394	Valved Tearway Introducer	Medcomp	2009	—
+3	K122422	Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved…	Care Fusion	2012	—
+4	K160437	PleurX Peritoneal Catheter System	Care Fusion	2016	—
+2	K120617	Ptfe Super Sheath Introducer	Martech Medical Products	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2009	1	0
2012	3	0
2013	3	0
2015	1	0
2016	3	0
2017	1	0
2020	1	0
2024	1	0

FIG. 1 — Lineage of K022513, 2000–2024Source: 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

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
*	K993191	TFX Medical Introducer Assembly Summary page 1 …Classification: DYB C.F.R. Section: 870.1340 C. Predicate Device: K993191 TFX Medical Introducer Assembly D. Device Description: The Medcomp Vascu-Sheath@ Introducer Set is a single use device u…	Tfx Medical, Inc.	2000	—

Also cleared against K993191: 3 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K053092	Medcomp Vascu-Sheath II	Medcomp	2006	14
K061135	Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019	Aesculap	2006	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K053092 (Medcomp, 2006) has gone furthest, with 14 descendants of its own.
3 other devices also cite its predicate K993191.

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)	—

What is it indicated for?

THE MEDCOMP Vascu-Sheath® INTRODUCER SETS ARE INDICATED FOR USE IN OBTAINING CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION OR PLACING PACING LEADS INTO THE CENTRAL VENOUS SYSTEM.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022513 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022513: Medcomp Vascu-Sheath Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022513

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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