510(k) · Cleared
Recalled · Class II · 2019GORE DrySeal Flex Introducer Sheath
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 May 12, 2016 as substantially equivalent to K121234 (W. L. Gore & Associates, Inc., 2012) and 1 other predicate after a 101-day review. Its family tree reaches back 4 generations to 2003. 1 of the 15 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- May 12, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K032073 (2003). 5 ancestors in all, the oldest K013282 (2001). 9 later devices descend from it, 6 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 3 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 2 generations backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- 1 generation backK121234 Gore (R) Dryseal Sheath with Hydrophilic CoatingW. L. Gore & Associates, Inc. · 2012
- This deviceK160254 GORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK222113 Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK241708 Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK171206 D'Vill IntroducerNuMED, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK260606 Echo Large Bore Introducer SheathEcho Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK260091 Aventus Introducer SheathInquis Medical · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241708 Abiomed 14Fr Low Profile Introducer Kit2 generations on · 2024
Most influential descendants
Showing 5 of 9 · See all- K222113Abiomed 14Fr Low Profile Introducer SetAbiomed, Inc. · 2022 · cites it directly2descendants
- K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · 2 generations on1descendant
- K171206D'Vill IntroducerNuMED, Inc. · 2017 · cites it directly1descendant
- K260606Echo Large Bore Introducer SheathEcho Medical, LLC · 2026 · cites it directly0descendants
- K260091Aventus Introducer SheathInquis Medical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K082356 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2008 | — |
| −2 | K093791 | Gore Dryseal Sheath | W. L. Gore & Associates, Inc. | 2010 | — |
| −1 | K121234 | Gore (R) Dryseal Sheath with Hydrophilic Coating | W. L. Gore & Associates, Inc. | 2012 | — |
| 0 (this device) | K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016 | — |
| +1 | K222113 | Abiomed 14Fr Low Profile Introducer Set | Abiomed, Inc. | 2022 | 1 |
| +2 | K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2024 | Class I |
| +1 | K171206 | D'Vill Introducer | NuMED, Inc. | 2017 | — |
| +1 | K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026 | — |
| +1 | K260091 | Aventus Introducer Sheath | Inquis Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 1 |
| 2025 | 2 | 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.
1 device in this family has 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? (2)
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 |
|---|---|---|---|
| * | K121234 | Gore (R) Dryseal Sheath with Hydrophilic CoatingSummary page 4…DYB 21CFR 870.1340 Classification Panel: Cardiovascular Devices Device Class: Class II Predicate Devices K121234 GORE® DrySeal Sheath with hydrophilic coating K093791 GORE® DrySeal Sheath… | 2012 |
| * | K093791 | Gore Dryseal SheathSummary page 4…0 Classification Panel: Cardiovascular Devices Device Class: Class II Predicate Devices K121234 GORE® DrySeal Sheath with hydrophilic coating K093791 GORE® DrySeal Sheath K160254… | 2010 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2019 | Class II | Z-1962-2020 | Labeling Change Control | The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices. |
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.
- K241708Abiomed 14Fr Low Profile Introducer KitAbiomed, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K222113 (Abiomed, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K121234.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160254: GORE DrySeal Flex Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160254
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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