510(k) Report

510(k) · Cleared

Cleared

Braided Guiding Introducer

K004026510(k) TraditionalCleared Jul 9, 2001194-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

Thomas Medical Products, Inc. · DYB Introducer, Catheter

Cleared on Jul 9, 2001 after a 194-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jul 9, 2001
Review
194 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2014: 1 descendant cleared2004: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK004026 Braided Guiding IntroducerThomas Medical Products, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK132720 Heartspan Fixed Curve Braided Transseptal SheathMerit Medical Systems, Inc. · 2014
  3. Descendant · cites it directly · 1 of its ownK013202 Modification to Braided Guiding IntroducerThomas Medical Products, Inc. · 2001
  4. Descendant · 2 generations on · 0 of its ownK171988 Performer Guiding SheathCook Incorporated · 2018
  5. Descendant · 2 generations on · 0 of its ownK040713 Modification to Braided Guiding Introducer SystemThomas Medical Products, Inc. · 2004 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K132720Heartspan Fixed Curve Braided Transseptal SheathMerit Medical Systems, Inc. · 2014 · cites it directly1descendant
  • K013202Modification to Braided Guiding IntroducerThomas Medical Products, Inc. · 2001 · cites it directly1descendant
  • K171988Performer Guiding SheathCook Incorporated · 2018 · 2 generations on0descendants
  • K040713Modification to Braided Guiding Introducer SystemThomas Medical Products, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K004026Braided Guiding IntroducerThomas Medical Products, Inc.2001—
+1K132720Heartspan Fixed Curve Braided Transseptal SheathMerit Medical Systems, Inc.2014—
+1K013202Modification to Braided Guiding IntroducerThomas Medical Products, Inc.2001—
+2K171988Performer Guiding SheathCook Incorporated2018—
+2K040713Modification to Braided Guiding Introducer SystemThomas Medical Products, Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
201410
201810
FIG. 1 — Lineage of K004026, 2001–2018Source: 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
Get a 510(k) Report

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? (4)

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

NumberDeviceApplicantDecidedDescendants
K132720Heartspan Fixed Curve Braided Transseptal SheathMerit Medical Systems, Inc.20141
K013202Modification to Braided Guiding IntroducerThomas Medical Products, Inc.20011

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?

  • Of its descendants, K132720 (Merit Medical Systems, Inc., 2014) has gone furthest, with 1 descendant 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 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/K004026 · printed Nov 5, 2026

Cite this page

510(k) Report. “K004026: Braided Guiding Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K004026

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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