510(k) · Cleared
Recalled · Class II · 2021Destino Twist, Steerable Guiding Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oscor, Inc. · DYB Introducer, Catheter
Cleared on Apr 17, 2014 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 17, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK140406 Destino Twist, Steerable Guiding SheathOscor, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 3 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
- Descendant · 4 generations on · 3 of its ownK251051 AuST Steerable SheathCenterPoint Systems, LLC · 2025
- Descendant · 5 generations on · 1 of its ownK260942 AuST Steerable SheathCenterPoint Systems, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151951Destino ReachOscor, Inc. · 2015 · cites it directly6descendants
- K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 2 generations on5descendants
- K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 3 generations on4descendants
- K251051AuST Steerable SheathCenterPoint Systems, LLC · 2025 · 4 generations on3descendants
- K260942AuST Steerable SheathCenterPoint Systems, LLC · 2026 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140406 | Destino Twist, Steerable Guiding Sheath | Oscor, Inc. | 2014 | — |
| +1 | K151951 | Destino Reach | Oscor, Inc. | 2015 | — |
| +2 | K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +3 | K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024 | — |
| +4 | K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025 | — |
| +5 | K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151951 | Destino Reach | 2015 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2021 | Class II | Z-0646-2022 | Process control | There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151951 (Oscor, Inc., 2015) has gone furthest, with 6 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. 2014, 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 steerable guiding shdath, model Destino Twist is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140406: Destino Twist, Steerable Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140406
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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