510(k) Report

510(k) · Cleared

Cleared

Modification to Medamicus Flowguard Peelable Introducer

K040150510(k) SpecialCleared Feb 18, 200426-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

Medamicus, Inc. · DYB Introducer, Catheter

Cleared on Feb 18, 2004 as substantially equivalent to K030905 (Medamicus, Inc., 2003) after a 26-day review. Its family tree reaches back 3 generations to 1993. 19 later devices descend from it.

Decided
Feb 18, 2004
Review
26 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K932323 (1993). 4 ancestors in all. 19 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2012: 3 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2004: 1 descendant cleared2013: 3 descendants cleared2010: 1 descendant cleared2007: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2016: 3 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant clearedK932323 · Percutaneous Introducer · Medamicus, Inc. · 1993K021004 · Valved Peelable Introducer · Medamicus, Inc. · 2002K030905 · Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K030905 · Medamicus Flowguard Peelable Introducer · Medamicus, Inc. · 2003K021004 · Valved Peelable Introducer · Medamicus, Inc. · 2002K932323 · Percutaneous Introducer · Medamicus, Inc. · 19930
  1. Root · 3 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
  2. 2 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
  3. 1 generation backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
  4. This deviceK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
  5. Descendant · cites it directly · 12 of its ownK090394 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 · 2 generations on · 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

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12007: 12009: 12010: 12012: 32013: 32015: 12016: 32017: 12018: 12020: 12024: 1
2004high 3 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 19 · See all
  • K090394Valved Tearway IntroducerMedcomp · 2009 · cites it directly12descendants
  • 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 · 2 generations on2descendants
  • K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200710
200910
201010
201230
201330
201510
201630
201710
201810
202010
202410
FIG. 1 — Lineage of K040150, 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? (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
*K030905Medamicus Flowguard Peelable Introducer
Summary page 1
…micus FlowGuard T Peelable Introducer Common Name Catheter Introducer Predicate Device MedAmicus FlowGuard T Peelable Introducer 510(k) K030905. Device Descrintion The MedAmicus FlowGuard T Peelable Introducer is a small diameter tubular shaped…
Medamicus, Inc.2003—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K090394Valved Tearway IntroducerMedcomp200912
K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124
K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122
K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc.20062
K042036Airguard Valved IntroducerC.R. Bard, Inc.20042

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 11 years and passes through 1 company; a new generation was cleared every 10 months on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K090394 (Medcomp, 2009) has gone furthest, with 12 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)—

What is it indicated for?

The MedAmicus FlowGuard Peelable Introducer in indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Indications for use as stated in the FDA summary.

More from Medamicus, Inc.

20 FDA decisions under this applicant name. See the company

  • K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
  • K022689Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
  • K021004Valved Peelable IntroducerMedamicus, Inc. · 2002
  • K020563Medamicus Axia RSNMedamicus, Inc. · 2002
  • K013120Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18Medamicus, Inc. · 2002

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/K040150 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040150: Modification to Medamicus Flowguard Peelable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040150

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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