510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

iSLEEVE Introducer Set

K180785510(k) TraditionalCleared Jun 22, 201888-day reviewClass II21 CFR 870.1340Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corporation · DYB Introducer, Catheter

Cleared on Jun 22, 2018 as substantially equivalent to K140338 (Creganna-Tactx Medical, 2014) after an 88-day review. Its family tree reaches back 4 generations to 1990. 7 later devices descend from it. It has been recalled once.

Decided
Jun 22, 2018
Review
88 days
Class
Class II
Product code
DYB
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K902469 (1990). 5 ancestors in all. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2019: 2 descendants cleared2020: 2 descendants cleared2023: 2 descendants cleared2025: 1 descendant clearedReference device: K152225 · Edwards eSheath Introducer Set · Edwards Lifesciences · 2015K902469 · Byrd Dilator Sheath Set - Teflon · Medical Engineering and Development Institute · 1990K031087 · Edwards Introducer Sheath · Edwards Lifesciences, LLC · 2003K093877 · Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 · Edwards Lifesciences, LLC · 2010K140338 · Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large) · Creganna-Tactx Medical · 20141990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K140338 · Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large) · Creganna-Tactx Medical · 2014K093877 · Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 · Edwards Lifesciences, LLC · 2010K031087 · Edwards Introducer Sheath · Edwards Lifesciences, LLC · 2003K902469 · Byrd Dilator Sheath Set - Teflon · Medical Engineering and Development Institute · 19900
  1. Root · 4 generations backK902469 Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
  2. 3 generations backK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
  3. 2 generations backK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
  4. 1 generation backK140338 Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus…Creganna-Tactx Medical · 2014
  5. This deviceK180785 iSLEEVE Introducer SetBoston Scientific Corporation · 2018
  6. Descendant · cites it directly · 4 of its ownK191871 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · Recalled
  7. Descendant · 2 generations on · 2 of its ownK230051 14F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023 · Recalled
  8. Descendant · 3 generations on · 1 of its ownK233503 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2023 · Recalled
  9. Descendant · 4 generations on · 0 of its ownK250468 iSLEEVE Introducer SetBoston Scientific · 2025
  10. Descendant · cites it directly · 0 of its ownK202330 Impella XR Sheath SetAbiomed, Inc. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2019: 22020: 22023: 22025: 1
2019high 2 (2019) · low 0 (2021)2026

Most influential descendants

Showing 5 of 7 · See all
  • K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · cites it directly4descendants
  • K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023 · 2 generations on2descendants
  • K23350314F iSLEEVE Introducer SetBoston Scientific Corporation · 2023 · 3 generations on1descendant
  • K250468iSLEEVE Introducer SetBoston Scientific · 2025 · 4 generations on0descendants
  • K202330Impella XR Sheath SetAbiomed, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K902469Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute1990—
−3K031087Edwards Introducer SheathEdwards Lifesciences, LLC2003—
−2K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC2010—
−1K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer…Creganna-Tactx Medical2014—
0 (this device)K180785iSLEEVE Introducer SetBoston Scientific Corporation2018—
+1K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation20191
+2K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation20231
+3K23350314F iSLEEVE Introducer SetBoston Scientific Corporation20231
+4K250468iSLEEVE Introducer SetBoston Scientific2025—
+1K202330Impella XR Sheath SetAbiomed, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202020
202320
202510
FIG. 1 — Lineage of K180785, 1990–2025Source: 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
*K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)
Summary page 4
…Catheter introducer Product Code DYB Classification Class II, 21 CFR Part 870.1340 Primary Predicate Creganna-Tactx K140338 27 August 2014 Device LotusTM Introducer Set Reference Edwards eSheath K152225…
Creganna-Tactx Medical2014—
†K152225Edwards eSheath Introducer SetEdwards Lifesciences2015—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation20194
K202330Impella XR Sheath SetAbiomed, Inc.20200
K190184iSLEEVE Introducer SetBoston Scientific20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 20, 2024Class IIZ-1390-2024Process controlBoston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K191871 (Boston Scientific Corporation, 2019) has gone furthest, with 4 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. 2018, 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 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the ACURATE TF Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm.

The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

Indications for use as stated in the FDA summary.

More from Boston Scientific Corporation

1,191 FDA decisions under this applicant name. See the company

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The DYB category page

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https://510kreport.com/device/K180785 · printed Nov 4, 2026

Cite this page

510(k) Report. “K180785: iSLEEVE Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180785

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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