510(k) · Cleared

Cleared

Galt Vti Low Insertion Valve Tearaway Introducer

K140028510(k) TraditionalCleared Aug 21, 2014227-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

Galt Medical Corp. · DYB Introducer, Catheter

Cleared on Aug 21, 2014 as substantially equivalent to K112398 (Galt Medical, 2012) after a 227-day review. Its family tree reaches back 3 generations to 2000.

Decided: Aug 21, 2014
Review: 227 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K000313 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
2 generations backK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
1 generation backK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
This deviceK140028 Galt Vti Low Insertion Valve Tearaway IntroducerGalt Medical Corp. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000313	Tearaway Introducer Sheath	Xentek Medical, Inc.	2000	1
−2	K043525	Catheter Introducer	Galt Medical Corp.	2005	3
−1	K112398	Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer…	Galt Medical	2012	2
0 (this device)	K140028	Galt Vti Low Insertion Valve Tearaway Introducer	Galt Medical Corp.	2014	—

FIG. 1 — Lineage of K140028, 2000–2014Source: 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
*	K112398	Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port Summary page 4 …ation Name: Catheter Introducer (DYB), 21 CFR 870.1340 Device Classification: Class Il (Cardiovascular) Predicate Device: Galt VTI® Valved Tearaway Introducer Sheath, K112398 6F-16F Manufacturer: Galt Medical 2220 Merritt Drive Garland, TX 75041 Establishment Registration Number: 1649395 Official Con…	Galt Medical	2012	2
†	K112389	Surgicase Connect, Surgicase Guide	Materialise NV	2012	—

Also cleared against K112398: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
3 of the 3 ancestors have a recall of any class.
2 other devices also cite its predicate K112398.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K140028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140028: Galt Vti Low Insertion Valve Tearaway Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140028

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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