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 Dec 13, 2012 as substantially equivalent to K061119 (Enpath Medical, Inc., 2006) and 1 other predicate after a 79-day review. Its family tree reaches back 6 generations to 1989. 7 later devices descend from it.
- Decided
- Dec 13, 2012
- Review
- 79 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K893658 (1989). 39 ancestors in all, the oldest K770977 (1977). 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 5 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 4 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 3 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 2 generations backK043489 Enpath Deflectable CatheterEnpath Medical Incorporated · 2005 · Recalled
- 1 generation backK061119 Enpath Medical Steerable SheathEnpath Medical, Inc. · 2006
- This deviceK122960 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 |
|---|---|---|---|---|---|
| −6 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −5 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −4 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −3 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −2 | K043489 | Enpath Deflectable Catheter | Enpath Medical Incorporated | 2005 | 2 |
| −1 | K061119 | Enpath Medical Steerable Sheath | Enpath Medical, Inc. | 2006 | — |
| 0 (this device) | K122960 | 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 |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K1212541 | Boston Scientific Z flex 270 Steerable Sheath Number could not be read | |
| * | K061119 | Enpath Medical Steerable SheathSummary page 1…Indications for Use statement. Predicate Device Boston Scientific, Z flex 270 Steerable Sheath, KI 12541 Information Enpath Medical, Steerable Sheath, K061 119 CryoCath Technologies, FlexCath Steerable Sheath, KO081049 Libeling and Intended Use Pro… | 2006 |
| * | K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Summary page 1…teerable Sheath, KI 12541 Information Enpath Medical, Steerable Sheath, K061 119 CryoCath Technologies, FlexCath Steerable Sheath, KO081049 Libeling and Intended Use Proposed TFU only with modified Indications for Use statement is attached.… | 2008 |
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 23 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 39 ancestors have a recall of any class.
- Of its descendants, K151951 (Oscor, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K061119.
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 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 summary.
https://510kreport.com/device/K122960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122960: 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/K122960
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