510(k) · Cleared
ClearedSteerable Guiding Sheath, Model Adelante Destino
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oscor, Inc. · DYB Introducer, Catheter
Cleared on Jun 29, 2012 as substantially equivalent to K101497 (Oscor, Inc., 2010) and 2 other predicates after a 135-day review. Its family tree reaches back 5 generations to 1997. 7 later devices descend from it.
- Decided
- Jun 29, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K964518 (1997). 25 ancestors in all, the oldest K924607 (1993). 7 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 4 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 3 generations backK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- 2 generations backK061015 Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006
- 1 generation backK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
- This deviceK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
- 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 |
|---|---|---|---|---|---|
| −5 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −4 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −3 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| −2 | K061015 | Fast-Cath Hemostasis Introducer and Transseptal Introducer | St Jude Medical | 2006 | — |
| −1 | K101497 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2010 | 30 |
| 0 (this device) | K120459 | Steerable Guiding Sheath, Model Adelante Destino | Oscor, Inc. | 2012 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
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 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? (3)
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 |
|---|---|---|---|
| * | K101497 | Delivery Sheath, Model Adelante BreezewaySummary page 1…stantial Equivalence The Adelante® Destino is substantially equivalent to the following predicate devices: 1) Oscor - Delivery Sheath, Model Adelante Breezeway 510k #K101497 2) St. Jude Medical - Agilis NxT Steerable Introducer 510k #K081645 3) Medltronic - Flexath Steerable Sheath 510Ok #K1 02… | 2010 |
| * | K081645 | Agilis NXT Steerable Introducer, Model G408324Summary page 1…o the following predicate devices: 1) Oscor - Delivery Sheath, Model Adelante Breezeway 510k #K101497 2) St. Jude Medical - Agilis NxT Steerable Introducer 510k #K081645 3) Medltronic - Flexath Steerable Sheath 510Ok #K1 02176 4. Device Description The steerable guiding sheath, model Adelante®… | 2008 |
| * | K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…Summary page 1…heath, Model Adelante Breezeway 510k #K101497 2) St. Jude Medical - Agilis NxT Steerable Introducer 510k #K081645 3) Medltronic - Flexath Steerable Sheath 510Ok #K1 02176 4. Device Description The steerable guiding sheath, model Adelante® Destino, is designed to assist with the introduction of intr… | 2010 |
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)
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 15 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 25 ancestors have a recall of any class.
- 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. 2012, 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 sheath, model Adelante Destino is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120459: Steerable Guiding Sheath, Model Adelante Destino.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120459
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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