510(k) Report

510(k) · Cleared

Cleared

Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V

K101604510(k) TraditionalCleared Jan 24, 2011230-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

Vascular Solutions, Inc. · DYB Introducer, Catheter

Cleared on Jan 24, 2011 as substantially equivalent to K990705 (Medamicus, Inc., 1999) and 1 other predicate after a 230-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it.

Decided
Jan 24, 2011
Review
230 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K932323 (1993). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2018: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK932323 · Percutaneous Introducer · Medamicus, Inc. · 1993K990705 · Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set · Medamicus, Inc. · 1999 · recalledK071574 · Stiffer Coaxial Micro-Introducer Kit · Enpath Medical, Inc. · 2007 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K071574 · Stiffer Coaxial Micro-Introducer Kit · Enpath Medical, Inc. · 2007 · recalledK990705 · Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set · Medamicus, Inc. · 1999 · recalledK932323 · Percutaneous Introducer · Medamicus, Inc. · 19930
  1. Root · 3 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
  2. 2 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
  3. 1 generation backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
  4. This deviceK101604 Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V…Vascular Solutions, Inc. · 2011
  5. Descendant · cites it directly · 4 of its ownK133114 Micropuncture Introducer SetCook Incorporated · 2014
  6. Descendant · 2 generations on · 2 of its ownK171275 Micropuncture Introducer Set, Micropuncture Introducer Set with…Cook Incorporated · 2017
  7. Descendant · 3 generations on · 0 of its ownK253526 NAMIC Dilator and SheathMedline Industries, LP · 2026
  8. Descendant · 3 generations on · 0 of its ownK240589 Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical · 2024
  9. Descendant · cites it directly · 0 of its ownK180913 VSI Micro-Introducer KitVascular Solutions, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12017: 12018: 22024: 12026: 1
2014high 2 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all
  • K133114Micropuncture Introducer SetCook Incorporated · 2014 · cites it directly4descendants
  • K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated · 2017 · 2 generations on2descendants
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026 · 3 generations on0descendants
  • K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical · 2024 · 3 generations on0descendants
  • K180913VSI Micro-Introducer KitVascular Solutions, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932323Percutaneous IntroducerMedamicus, Inc.1993—
−2K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator…Medamicus, Inc.19991
−1K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc.20072
0 (this device)K101604Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V…Vascular Solutions, Inc.2011—
+1K133114Micropuncture Introducer SetCook Incorporated2014—
+2K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus…Cook Incorporated2017—
+3K253526NAMIC Dilator and SheathMedline Industries, LP2026—
+3K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical2024—
+1K180913VSI Micro-Introducer KitVascular Solutions, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
201820
202410
202610
FIG. 1 — Lineage of K101604, 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
*K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set
Summary page 1
…ucer Set Common!/ Usual Name Catheter introducer Classification Name 870.1340; DYB; Catheter introducer; Class 11 Predicate Devices K990705 Coaxial Micro-Introducer Set - Standard (Greatbatch Medical) K071…
Medamicus, Inc.19991
*K071574Stiffer Coaxial Micro-Introducer Kit
Summary page 1
…s 11 Predicate Devices K990705 Coaxial Micro-Introducer Set - Standard (Greatbatch Medical) K071574 Coaxial Micro-Introducer Set - Stiffen (Greatbatch Medical)…
Enpath Medical, Inc.20072

Also cleared against K990705: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K133114Micropuncture Introducer SetCook Incorporated20144
K180913VSI Micro-Introducer KitVascular Solutions, Inc.20180

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 18 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • 3 of the 4 ancestors have a recall of any class.
  • Of its descendants, K133114 (Cook Incorporated, 2014) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K990705.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 VSI Micro-Introducer Set is used for percutaneous introduction of up to an 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Indications for use as stated in the FDA summary.

Also cleared against K990705

3 other devices cite the same predicate.

  • K091954Micro-Stick SetMedcomp · 2010
  • K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 20072 recalls
  • K994097Medamicus Epidural IntroducerMedamicus, Inc. · 2000

More from Vascular Solutions, Inc.

135 FDA decisions under this applicant name. See the company

  • P990037/S036Duett Sealing Device (D-Stat Flowable)Vascular Solutions, Inc. · 2022
  • P990037/S035Duett Sealing DeviceVascular Solutions, Inc. · 2021
  • K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. · 2018
  • K181647Bandit guidewireVascular Solutions, Inc. · 2018
  • K180913VSI Micro-Introducer KitVascular Solutions, Inc. · 2018

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/K101604 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101604: Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101604

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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