510(k) Report

510(k) · Cleared

Cleared

Modification to Ivs Introducer Set, Model 1003

K031583510(k) SpecialCleared Jun 16, 200326-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

Integrated Vascular Systems, Inc. · DYB Introducer, Catheter

Cleared on Jun 16, 2003 as substantially equivalent to K030723 (Integrated Vascular Systems, Inc., 2003) after a 26-day review. Its family tree reaches back 2 generations to 2002.

Decided
Jun 16, 2003
Review
26 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K020879 (2002). No later device cites it as a predicate yet.

K020879 · Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001 · Integrated Vascular Systems, Inc. · 2002K030723 · Ivs Introducer Set, Model 1003 · Integrated Vascular Systems, Inc. · 2003200020022004
K030723 · Ivs Introducer Set, Model 1003 · Integrated Vascular Systems, Inc. · 2003K020879 · Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001 · Integrated Vascular Systems, Inc. · 20020
  1. Root · 2 generations backK020879 Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs…Integrated Vascular Systems, Inc. · 2002
  2. 1 generation backK030723 Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003
  3. This deviceK031583 Modification to Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K020879Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set…Integrated Vascular Systems, Inc.2002—
−1K030723Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc.2003—
0 (this device)K031583Modification to Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc.2003—
FIG. 1 — Lineage of K031583, 2002–2003Source: 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? (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
*K030723Ivs Introducer Set, Model 1003
Summary page 1
…Technological characteristics: The Model 1003-7 Introducer Set has the same technologic characteristics as the Model 1003-6 (K030723) device. Testing: The IVS Introducer Set is tested in vitro and in clinical model systems.…
Integrated Vascular Systems, Inc.2003—

Also cleared against K030723: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 1 year and passes through 1 company; a new generation was cleared every 6 months on median.
  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K030723.

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 IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.

Indications for use as stated in the FDA summary.

Also cleared against K030723

1 other device cites the same predicate.

  • K060902Starclose Introducer Set Model- 1002Abbott Vascular, Inc. · 20061 recall

More from Integrated Vascular Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K030723Ivs Introducer Set, Model 1003Integrated Vascular Systems, Inc. · 2003
  • K020879Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001Integrated Vascular Systems, 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/K031583 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031583: Modification to Ivs Introducer Set, Model 1003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031583

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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