510(k) Report

510(k) · Cleared

Cleared

Reinforced Catheter Introducer System (Rcis)

K081341510(k) TraditionalCleared May 14, 20081-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 May 14, 2008 as substantially equivalent to K970229 (Arrow Intl., Inc., 1998) and 1 other predicate after a 1-day review. Its family tree reaches back 3 generations to 1993. 13 later devices descend from it.

Decided
May 14, 2008
Review
1 day
Class
Class II
Product code
DYB
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K924607 (1993). 4 ancestors in all. 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2012: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2021: 1 descendant cleared2015: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 3 descendants clearedK924607 · Arrow Fischell Kink Resist Percut Sheath Intro Set · Arrow Intl., Inc. · 1993 · recalledK012812 · Carotid Guiding Sheath · Terumo Medical Corp. · 2001 · recalledK051601 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 2 descendants8 generations forward: 1 descendant K051601 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2005K012812 · Carotid Guiding Sheath · Terumo Medical Corp. · 2001 · recalledK924607 · Arrow Fischell Kink Resist Percut Sheath Intro Set · Arrow Intl., Inc. · 1993 · recalled0+5
  1. Root · 3 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
  2. 2 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
  3. 1 generation backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
  4. This deviceK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008
  5. Descendant · cites it directly · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
  6. Descendant · 2 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
  7. Descendant · 3 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
  8. Descendant · 4 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
  9. Descendant · 5 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 22015: 12021: 12024: 32025: 12026: 3
2009high 3 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 13 · See all
  • K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · cites it directly8descendants
  • K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 2 generations on7descendants
  • K151951Destino ReachOscor, Inc. · 2015 · 3 generations on6descendants
  • K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on5descendants
  • K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K924607Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc.19933
−2K012812Carotid Guiding SheathTerumo Medical Corp.20011
−1K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2005—
0 (this device)K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc.2008—
+1K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.201030
+2K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.2012—
+3K151951Destino ReachOscor, Inc.2015—
+4K240829AuST Steerable SheathCenterPoint Systems, LLC2024—
+5K242106AuST Steerable SheathCenterPoint Systems, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201220
201510
202110
202430
202510
202630
FIG. 1 — Lineage of K081341, 1993–2026Source: 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), 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? (2)

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
*K970229Arrow Transseptal Super Arrow-Flex Percutaneous Set
Summary page 1
…tem (RCIS) C. Legally marketed device to which equivalence is claimed: Arrow Transseptal Super Arrow-Flex Percutaneous Sheath (K970229) Terumo Medical Corporation Pinnacle Destination Peripheral Guiding Sheath (KO…
Arrow Intl., Inc.1998—
*K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2005—

Also cleared against K970229: 5 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.20108
K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.20122
K083269CrossoverThomas Medical Products, Inc.20090

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 15 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K101497 (Oscor, Inc., 2010) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K970229.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

Indications for use as stated in the FDA summary.

Also cleared against K970229

5 other devices cite the same predicate.

  • K171988Performer Guiding SheathCook Incorporated · 2018
  • K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 201230 recalls
  • K083793Steerable Guide CatheterEvalve, Inc. · 2009
  • K043084Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
  • K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc. · 20042 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
  • K072745Y-GlideThomas Medical Products, Inc. · 20082 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/K081341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081341: Reinforced Catheter Introducer System (Rcis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081341

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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