510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Catheter Introducer

K043525510(k) SpecialCleared Feb 9, 200550-day reviewClass II21 CFR 870.1340Recalls 3

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 Feb 9, 2005 as substantially equivalent to K000313 (Xentek Medical, Inc., 2000) after a 50-day review. Its family tree reaches back 1 generation to 2000. 15 later devices descend from it. It has been recalled 3 times.

Decided
Feb 9, 2005
Review
50 days
Class
Class II
Product code
DYB
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K000313 (2000). 15 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2017: 4 descendants cleared2015: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2019: 2 descendants cleared2016: 1 descendant cleared2022: 1 descendant cleared2026: 2 descendants clearedK000313 · Tearaway Introducer Sheath · Xentek Medical, Inc. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K000313 · Tearaway Introducer Sheath · Xentek Medical, Inc. · 2000 · recalled0+5
  1. Root · 1 generation backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
  2. This deviceK043525 Catheter IntroducerGalt Medical Corp. · 2005
  3. Descendant · cites it directly · 11 of its ownK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK123430 Microslider Tearaway Introducer SetGalt Medical Corp. · 2013
  5. Descendant · 3 generations on · 4 of its ownK153533 Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · Recalled
  6. Descendant · cites it directly · 3 of its ownK152528 Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015
  7. Descendant · 2 generations on · 1 of its ownK182660 GaltTWSGalt Medical Corp. · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12015: 12016: 12017: 42018: 12019: 22022: 12026: 2
2012high 4 (2017) · low 0 (2020)2026

Most influential descendants

Showing 5 of 15 · See all
  • K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortGalt Medical · 2012 · cites it directly11descendants
  • K123430Microslider Tearaway Introducer SetGalt Medical Corp. · 2013 · 2 generations on5descendants
  • K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · 3 generations on4descendants
  • K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015 · cites it directly3descendants
  • K182660GaltTWSGalt Medical Corp. · 2019 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000313Tearaway Introducer SheathXentek Medical, Inc.20001
0 (this device)K043525Catheter IntroducerGalt Medical Corp.2005—
+1K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer…Galt Medical20122
+2K123430Microslider Tearaway Introducer SetGalt Medical Corp.2013—
+3K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.20162
+1K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp.2015—
+2K182660GaltTWSGalt Medical Corp.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201510
201610
201740
201810
201920
202210
202620
FIG. 1 — Lineage of K043525, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K000313Tearaway Introducer Sheath
Summary page 1
…equivalent to Catheter (3) Substantial Equivalency: Gait Medical Catheter Introducer is substantially Introducers from: Gait K000313 presently in (4) Device Description: The ma…
Xentek Medical, Inc.20001

Also cleared against K000313: 5 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortGalt Medical201211
K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp.20153
K171557AcQRef Introducer SheathAcutus Medical, Inc.20181
K173287Elite HV RadialGalt Medical Corp.20170
K170695VenaCure EVLT NeverTouch Direct Introducer SheathAngioDynamics, Inc.20170

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 27, 2025Class IIZ-1733-2025Process controlDue to a potential open seal in the sterile barrier packaging .
May 2, 2018Class IIZ-2562-2018OtherThe products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce…
May 2, 2018Class IIZ-2558-2018OtherThe products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K112398 (Galt Medical, 2012) has gone furthest, with 11 descendants of its own.
  • 5 other devices also cite its predicate K000313.

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

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
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

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K000313

5 other devices cite the same predicate.

  • K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 20162 recalls
  • K123430Microslider Tearaway Introducer SetGalt Medical Corp. · 2013
  • K122854Arrow Glidethru Peel-Away Sheath/Dilator IntroducerArrow International (Subsidiary of Teleflex Inc.) · 20132 recalls
  • K120617Ptfe Super Sheath IntroducerMartech Medical Products · 2012
  • K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortGalt Medical · 20122 recalls

More from Galt Medical Corp.

14 FDA decisions under this applicant name. See the company

  • K192195Sterile DilatorGalt Medical Corp. · 2019
  • K182660GaltTWSGalt Medical Corp. · 2019
  • K173287Elite HV RadialGalt Medical Corp. · 20172 recalls
  • K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. · 20172 recalls
  • K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 20162 recalls

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K043525 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043525: Catheter Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043525

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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