510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Large Bore Splittable Introducer Kit

K043438510(k) SpecialCleared Feb 15, 200563-day reviewClass II21 CFR 870.1340Recalls 1 (1 Class I)

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

Thomas Medical Products, Inc. · DYB Introducer, Catheter

Cleared on Feb 15, 2005 as substantially equivalent to K934901 (Thomas Medical Products, Inc., 1994) after a 63-day review. Its family tree reaches back 1 generation to 1994. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
Feb 15, 2005
Review
63 days
Class
Class II
Product code
DYB
Recalls
1 (1 Class I)
Predicates
1

Its longest line of descent runs back 1 generation to K934901 (1994). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

K934901 · Tear-Away Sheath Introducer Set with Integral Hemostasis Valve · Thomas Medical Products, Inc. · 1994 · recalled1990199520002005
K934901 · Tear-Away Sheath Introducer Set with Integral Hemostasis Valve · Thomas Medical Products, Inc. · 1994 · recalled0
  1. Root · 1 generation backK934901 Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. · 1994 · Recalled
  2. This deviceK043438 Large Bore Splittable Introducer KitThomas Medical Products, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934901Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc.19947
0 (this device)K043438Large Bore Splittable Introducer KitThomas Medical Products, Inc.2005—
FIG. 1 — Lineage of K043438, 1994–2005Source: 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), 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.

1 device in this family has a Class I recall. 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? (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
*K934901Tear-Away Sheath Introducer Set with Integral Hemostasis Valve
Summary page 1
…C. Legally marketed device to which equivalence is claimed: Thomas Medical Products, Inc., Tear-away sheath introducer kit - k934901 D. Description of the device: The Thomas Medical Products Inc. Large bore splittable…
Thomas Medical Products, Inc.19947

Also cleared against K934901: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 13, 2026Class IZ-1577-2026Process control16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 2 other devices also cite its predicate K934901.

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?

For the introduction of various types of pacing or defibrillator leads and catheters.

For the introduction of various types of catheters.

Indications for use as stated in the FDA summary.

Also cleared against K934901

2 other devices cite the same predicate.

  • K143255Prelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc. · 20154 recalls
  • K122084Introducer Set, Model Adelante-S SeriesOscor, Inc. · 20123 Class I recalls

More from Thomas Medical Products, Inc.

23 FDA decisions under this applicant name. See the company

  • K122431Heartspan Steerable Introducer KitThomas Medical Products, Inc. · 2013
  • K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 20122 recalls
  • K101015Guide Catheters and AccessoriesThomas Medical Products, Inc. · 2010
  • K083269CrossoverThomas Medical Products, Inc. · 20092 recalls
  • K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008

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/K043438 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043438: Large Bore Splittable Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043438

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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