510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Tearaway Introducer Sheath

K000313510(k) TraditionalCleared Jun 16, 2000136-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

Xentek Medical, Inc. · DYB Introducer, Catheter

Cleared on Jun 16, 2000 after a 136-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it. It has been recalled once.

Decided
Jun 16, 2000
Review
136 days
Class
Class II
Product code
DYB
Recalls
1
Predicates
0

20 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2016: 2 descendants cleared2012: 2 descendants cleared2013: 3 descendants cleared2017: 4 descendants cleared2015: 1 descendant cleared2018: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2019: 2 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000
  2. Descendant · cites it directly · 15 of its ownK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
  3. Descendant · cites it directly · 11 of its ownK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
  4. Descendant · cites it directly · 5 of its ownK123430 Microslider Tearaway Introducer SetGalt Medical Corp. · 2013
  5. Descendant · cites it directly · 4 of its ownK153533 Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · Recalled
  6. Descendant · 2 generations on · 3 of its ownK152528 Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005: 12012: 22013: 32014: 12015: 12016: 22017: 42018: 12019: 22022: 12026: 2
2005high 4 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 20 · See all
  • K043525Catheter IntroducerGalt Medical Corp. · 2005 · cites it directly15descendants
  • 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 · cites it directly5descendants
  • K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · cites it directly4descendants
  • K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000313Tearaway Introducer SheathXentek Medical, Inc.2000—
+1K043525Catheter IntroducerGalt Medical Corp.20053
+1K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer…Galt Medical20122
+1K123430Microslider Tearaway Introducer SetGalt Medical Corp.2013—
+1K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.20162
+2K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201220
201330
201410
201510
201620
201740
201810
201920
202210
202620
FIG. 1 — Lineage of K000313, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K043525Catheter IntroducerGalt Medical Corp.200515
K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortGalt Medical201211
K123430Microslider Tearaway Introducer SetGalt Medical Corp.20135
K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.20164
K120617Ptfe Super Sheath IntroducerMartech Medical Products20122
K122854Arrow Glidethru Peel-Away Sheath/Dilator IntroducerArrow International (Subsidiary of Teleflex Inc.)20130

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

Recalls of this device

DateClassRecallRoot causeReason
May 10, 2018Class IIZ-2197-2018Material/Component ContaminationA component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K043525 (Galt Medical Corp., 2005) has gone furthest, with 15 descendants of its own.

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)—

More from Xentek Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K000737Coaxial Dilator SetXentek Medical, Inc. · 20005 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/K000313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000313: Tearaway Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000313

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026