510(k) · Cleared
ClearedConfida Adaptive Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DYB Introducer, Catheter
Cleared on Aug 7, 2015 as substantially equivalent to K123990 (Medtronic Vascular, 2013) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 2003. 1 of the 13 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 7, 2015
- Review
- 15 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K032073 (2003). 12 ancestors in all, the oldest K902469 (1990). No later device cites it as a predicate yet. 1 of the 13 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 backK123990 Sentrant Introducer Sheath with Hydrophilic CoatingMedtronic Vascular · 2013
- This deviceK152054 Confida Adaptive SheathMedtronic, Inc. · 2015
Class I recalls in this family
- K100819 The Solopath Balloon Expandable Transfemoral…2 generations back · 2010
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 | K123990 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular | 2013 | — |
| 0 (this device) | K152054 | Confida Adaptive Sheath | Medtronic, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 1 |
| 2014 | 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.
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 |
|---|---|---|---|
| * | K123990 | Sentrant Introducer Sheath with Hydrophilic CoatingSummary page 4…roduct Code: DYB Predicate Devices: Primary Predicate Device: Medtronic Sentrant Introducer Sheath with Hydrophilic Coating (K123990, cleared April 26, 2013) Secondary Predicate Device: Edwards eSheath Introducer Set… | 2013 |
| * | K141696 | Edwards Esheath Introducer SetSummary page 4…Hydrophilic Coating (K123990, cleared April 26, 2013) Secondary Predicate Device: Edwards eSheath Introducer Set (K141696, cleared September 18, 2014) Device Description: The Confida™ Adaptive Sheath is a single-use, disposable, hydrophilically-… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 12 ancestors has a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K123990.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Confida™ Adaptive Sheath is intended to provide a conduit through the iliofemoral vessels for the insertion of diagnostic or interventional devices used during cardiovascular procedures, including transcatheter aortic valve replacement (TAVR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152054: Confida Adaptive Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152054
Report an extraction error
Are you the manufacturer?
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