510(k) Report

510(k) · Cleared

Cleared

Valved Tearway Introducer

K090394510(k) TraditionalCleared Sep 1, 2009196-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

Medcomp · DYB Introducer, Catheter

Cleared on Sep 1, 2009 as substantially equivalent to K040150 (Medamicus, Inc., 2004) and 1 other predicate after a 196-day review. Its family tree reaches back 4 generations to 1993. 12 later devices descend from it.

Decided
Sep 1, 2009
Review
196 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K932323 (1993). 8 ancestors in all. 12 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestors2013: 2 descendants cleared2012: 3 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared2016: 3 descendants cleared2020: 1 descendant cleared2024: 1 descendant clearedK932323 · Percutaneous Introducer · Medamicus, Inc. · 1993K021004 · Valved Peelable Introducer · Medamicus, Inc. · 2002K030905 · Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2003K040150 · Modification to Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K040150 · Modification to Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2004K030905 · Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2003K021004 · Valved Peelable Introducer · Medamicus, Inc. · 2002K932323 · Percutaneous Introducer · Medamicus, Inc. · 19930
  1. Root · 4 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
  2. 3 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
  3. 2 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
  4. 1 generation backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
  5. This deviceK090394 Valved Tearway IntroducerMedcomp · 2009
  6. Descendant · cites it directly · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
  7. Descendant · 2 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
  8. Descendant · cites it directly · 2 of its ownK120617 Ptfe Super Sheath IntroducerMartech Medical Products · 2012
  9. Descendant · cites it directly · 2 of its ownK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
  10. Descendant · 3 generations on · 1 of its ownK201155 PleurX Peritoneal Catheter SystemCare Fusion · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2012: 32013: 22015: 12016: 32017: 12020: 12024: 1
2012high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 12 · See all
  • K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · cites it directly4descendants
  • K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 2 generations on2descendants
  • K120617Ptfe Super Sheath IntroducerMartech Medical Products · 2012 · cites it directly2descendants
  • K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · cites it directly2descendants
  • K201155PleurX Peritoneal Catheter SystemCare Fusion · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K932323Percutaneous IntroducerMedamicus, Inc.1993—
−3K021004Valved Peelable IntroducerMedamicus, Inc.2002—
−2K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc.2003—
−1K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc.2004—
0 (this device)K090394Valved Tearway IntroducerMedcomp2009—
+1K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved…Care Fusion2012—
+2K160437PleurX Peritoneal Catheter SystemCare Fusion2016—
+1K120617Ptfe Super Sheath IntroducerMartech Medical Products2012—
+1K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter…Care Fusion2012—
+3K201155PleurX Peritoneal Catheter SystemCare Fusion2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201320
201510
201630
201710
202010
202410
FIG. 1 — Lineage of K090394, 1993–2024Source: 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? (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
*K040150Modification to Medamicus Flowguard Peelable Introducer
Summary page 1
…Introducer, Catheter Classification: DYB C.F.R. Section: 870.1340 C. Predicate Device: K040150 MedAmicus FlowGuard TM Peelable Introducer…
Medamicus, Inc.2004—
*K053092Medcomp Vascu-Sheath II
Summary page 1
…ice: K040150 MedAmicus FlowGuard TM Peelable Introducer K053092 Medcomp Vascu-Sheath® II Introducer Set D. Device Description: The Me…
Medcomp2006—

Also cleared against K040150: 4 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124
K120617Ptfe Super Sheath IntroducerMartech Medical Products20122
K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122
K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130

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 16 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K122422 (Care Fusion, 2012) has gone furthest, with 4 descendants of its own.
  • 4 other devices also cite its predicate K040150.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 VALVED TEARAWAY INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.

Indications for use as stated in the FDA summary.

Also cleared against K040150

4 other devices cite the same predicate.

  • K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable IntroducerCare Fusion · 2012
  • K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx…Care Fusion · 2012
  • K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc. · 2006
  • K042036Airguard Valved IntroducerC.R. Bard, Inc. · 2004

More from Medcomp

40 FDA decisions under this applicant name. See the company

  • K130889Split Cath RGMedcomp · 2014
  • K123292T3Medcomp · 2013
  • K1029662.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010
  • K091954Micro-Stick SetMedcomp · 2010
  • K091953Pro-PiccMedcomp · 2009

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/K090394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090394: Valved Tearway Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090394

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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