510(k) · Cleared
ClearedAncure Sheath Model # 40315, 40320, 40325
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Cardiac and Vascular Surgery · DYB Introducer, Catheter
Cleared on Jan 24, 2002 after a 402-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jan 24, 2002
- Review
- 402 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK003889 Ancure Sheath Model # 40315, 40320, 40325Guidant Cardiac and Vascular Surgery · 2002
- Descendant · cites it directly · 17 of its ownK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
- Descendant · cites it directly · 16 of its ownK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
- Descendant · 2 generations on · 8 of its ownK140338 Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus…Creganna-Tactx Medical · 2014
- Descendant · 3 generations on · 7 of its ownK180785 iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · Recalled
- Descendant · 4 generations on · 4 of its ownK191871 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K031087Edwards Introducer SheathEdwards Lifesciences, LLC · 2003 · cites it directly17descendants
- K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010 · cites it directly16descendants
- K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)Creganna-Tactx Medical · 2014 · 2 generations on8descendants
- K180785iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · 3 generations on7descendants
- K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003889 | Ancure Sheath Model # 40315, 40320, 40325 | Guidant Cardiac and Vascular Surgery | 2002 | — |
| +1 | K031087 | Edwards Introducer Sheath | Edwards Lifesciences, LLC | 2003 | — |
| +1 | 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 | — |
| +3 | K180785 | iSLEEVE Introducer Set | Boston Scientific Corporation | 2018 | 1 |
| +4 | K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031087 (Edwards Lifesciences, LLC, 2003) has gone furthest, with 17 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K003889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003889: Ancure Sheath Model # 40315, 40320, 40325.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003889
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026