510(k) · Cleared
ClearedSentrant Introducer Sheath with Hydrophilic Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DYB Introducer, Catheter
Cleared on Apr 26, 2013 as substantially equivalent to K902469 (Medical Engineering and Development Institute, 1990) and 1 other predicate after a 121-day review. Its family tree reaches back 3 generations to 2003. 7 later devices descend from it.
- Decided
- Apr 26, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032073 (2003). 5 ancestors in all, the oldest K902469 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK032073 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2003
- 2 generations backK082356 Gore Introducer Sheath with Silicone Pinch ValveW. L. Gore & Associates, Inc. · 2008
- 1 generation backK093791 Gore Dryseal SheathW. L. Gore & Associates, Inc. · 2010
- This deviceK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013
- Descendant · cites it directly · 3 of its ownK140793 Nanostim Introducer KitSt. Jude Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK160716 The Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK171866 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK161102 Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK252309 PerQseal IntroducersVivasure Medical Limited · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140793Nanostim Introducer KitSt. Jude Medical, Inc. · 2014 · cites it directly3descendants
- K160716The Nanostim Introducer KitSt. Jude Medical, Inc. · 2016 · 2 generations on2descendants
- K171866Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular, Inc. · 2017 · cites it directly1descendant
- K161102Nanostim Introducer KitSt. Jude Medical, Inc. · 2016 · 3 generations on1descendant
- K252309PerQseal IntroducersVivasure Medical Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K123990 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular | 2013 | — |
| +1 | K140793 | Nanostim Introducer Kit | St. Jude Medical, Inc. | 2014 | — |
| +2 | K160716 | The Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016 | — |
| +1 | K171866 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular, Inc. | 2017 | — |
| +3 | K161102 | Nanostim Introducer Kit | St. Jude Medical, Inc. | 2016 | — |
| +2 | K252309 | PerQseal Introducers | Vivasure Medical Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 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? (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 |
|---|---|---|---|
| * | K902469 | Byrd Dilator Sheath Set - TeflonSummary page 1…DYB Classification Panel: Cardiovascular Predicate Devices: Cook Extra Large Check-Flo® Introducer (K902469) GORE Dry Seal Sheath (K093791) Medfronic Vascular Senfrant Introducer She… | 1990 |
| * | K093791 | Gore Dryseal SheathSummary page 1…Predicate Devices: Cook Extra Large Check-Flo® Introducer (K902469) GORE Dry Seal Sheath (K093791) Medfronic Vascular Senfrant Introducer Sheathi with Hydrophilic Coaling Tradilional 510(k) Subnission === Page… | 2010 |
What descends from it? (7)
3 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140793 (St. Jude Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K902469.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123990: Sentrant Introducer Sheath with Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123990
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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