510(k) · Cleared
Recalled · Class II · 202415F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DYB Introducer, Catheter
Cleared on Aug 7, 2019 as substantially equivalent to K180785 (Boston Scientific Corporation, 2018) after a 26-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2019
- Review
- 26 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902469 (1990). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK902469 Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
- 4 generations backK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
- 3 generations backK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
- 2 generations backK140338 Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus…Creganna-Tactx Medical · 2014
- 1 generation backK180785 iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · Recalled
- This deviceK191871 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019
- Descendant · cites it directly · 2 of its ownK230051 14F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK233503 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK250468 iSLEEVE Introducer SetBoston Scientific · 2025
- Descendant · cites it directly · 0 of its ownK202584 iSleeve Introducer SetBoston Scientific Corporation · 2020
Most influential descendants
Showing 4 of 4 · See all- K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023 · cites it directly2descendants
- K23350314F iSLEEVE Introducer SetBoston Scientific Corporation · 2023 · 2 generations on1descendant
- K250468iSLEEVE Introducer SetBoston Scientific · 2025 · 3 generations on0descendants
- K202584iSleeve Introducer SetBoston Scientific Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902469 | Byrd Dilator Sheath Set - Teflon | Medical Engineering and Development Institute | 1990 | — |
| −4 | K031087 | Edwards Introducer Sheath | Edwards Lifesciences, LLC | 2003 | — |
| −3 | K093877 | Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 | Edwards Lifesciences, LLC | 2010 | — |
| −2 | K140338 | Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer… | Creganna-Tactx Medical | 2014 | — |
| −1 | K180785 | iSLEEVE Introducer Set | Boston Scientific Corporation | 2018 | 1 |
| 0 (this device) | K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2019 | — |
| +1 | K230051 | 14F iSLEEVE™ Introducer Set | Boston Scientific Corporation | 2023 | 1 |
| +2 | K233503 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2023 | 1 |
| +3 | K250468 | iSLEEVE Introducer Set | Boston Scientific | 2025 | — |
| +1 | K202584 | iSleeve Introducer Set | Boston Scientific Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
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 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180785 | iSLEEVE Introducer SetSummary page 4…Catheter Introducer Product Code DYB Classification Class II, 21 CFR Part 870.1340 Predicate Device iSLEEVETM Introducer Set K180785 22 June 2018 Device Description The iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percu… | 2018 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2024 | Class II | Z-1390-2024 | Process control | Boston 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 29 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K230051 (Boston Scientific Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K180785.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
14F iSLEEVE Introducer Set:
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 diameter.
15F iSLEEVE Introducer Set:
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.
https://510kreport.com/device/K191871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191871: 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191871
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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