510(k) · Cleared
ClearedGore Introducer Sheath with Silicone Pinch Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DYB Introducer, Catheter
Cleared on Aug 13, 2003 after a 41-day review. The FDA summary names no predicate by number. 3 of the 43 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it.
- Decided
- Aug 13, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 3 citing it directly. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- This deviceK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- Descendant · cites it directly · 41 of its ownK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- Descendant · cites it directly · 32 of its ownK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- Descendant · 2 generations on · 18 of its ownK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK160254 GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 7 of its ownK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 42 · See all- K082356Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008 · cites it directly41descendants
- K093791Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010 · cites it directly32descendants
- K121234Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012 · 2 generations on18descendants
- K160254GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016 · 2 generations on9descendants
- K123990Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| +1 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| +1 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| +2 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| +2 | K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016 | 1 |
| +2 | K123990 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 1 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 1 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 1 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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.
3 devices in this family have a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (42)
See all 423 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K082356 (W. L. Gore & Associates, Inc., 2008) has gone furthest, with 41 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) | — |
What is it indicated for?
Intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032073: Gore Introducer Sheath with Silicone Pinch Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032073
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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