510(k) · Cleared
Recalled · Class II · 2016Delivery Sheath, Model Adelante Breezeway
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 K081341 (Thomas Medical Products, Inc., 2008) and 2 other predicates after a 79-day review. Its family tree reaches back 4 generations to 1993. 2 later devices descend from it. It has been recalled 30 times.
- Decided
- Dec 13, 2012
- Review
- 79 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 30
- Predicates
- 3
Its longest line of descent runs back 4 generations to K924607 (1993). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 3 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 2 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 1 generation backK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008
- This deviceK122958 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK210627 Breezeway IIOscor, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK242756 Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075…Pulnovo Medical (Wuxi) Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −3 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −2 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −1 | K081341 | Reinforced Catheter Introducer System (Rcis) | Thomas Medical Products, Inc. | 2008 | — |
| 0 (this device) | K122958 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2012 | — |
| +1 | K210627 | Breezeway II | Oscor, Inc. | 2021 | — |
| +2 | K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080… | Pulnovo Medical (Wuxi) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K081341 | Reinforced Catheter Introducer System (Rcis)Summary page 1…aditional Reason for 510Ok Addition of indications into the Indications for Use statement. Predicate Device Thomas Medical; Reinforced Catheter Introducer system, KO081341 Information Terumo Medical Corn., Destination Guiding Sheath, KO081045 Arrow (sub. Teleflex)… | 2008 |
| * | K081045 | Destination Renal Guiding SheathSummary page 1…ement. Predicate Device Thomas Medical; Reinforced Catheter Introducer system, KO081341 Information Terumo Medical Corn., Destination Guiding Sheath, KO081045 Arrow (sub. Teleflex), Arrow-Flex Sheath Introducer Set, K970229 IkV'llngd' Indications for… | 2008 |
| * | K970229 | Arrow Transseptal Super Arrow-Flex Percutaneous SetSummary page 1…1341 Information Terumo Medical Corn., Destination Guiding Sheath, KO081045 Arrow (sub. Teleflex), Arrow-Flex Sheath Introducer Set, K970229 IkV'llngd' Indications for Proposed IFU only with modified fIdica.tions for Use statement is attached. Use… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210627 | Breezeway II | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2016 | Class II | Z-0796-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0798-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0800-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0805-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0806-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0810-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0792-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0793-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0795-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0797-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0799-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0803-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0790-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0791-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0794-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0802-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0804-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0811-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0812-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0813-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0814-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0816-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0818-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0801-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0807-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0808-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0809-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0815-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0817-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Oct 5, 2016 | Class II | Z-0819-2017 | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
The 5 latest of 30 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K210627 (Oscor, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K081341.
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
2007high 30 (2014) · low 9 (2020)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
2007high 156 (2018) · low 37 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
2007high 45 (2016) · low 1 (2018)2026
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
2007high 4,539 (2025) · low 316 (2007)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 Adelante® Breezeway Delivery Sheath 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/K122958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122958: Delivery Sheath, Model Adelante Breezeway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122958
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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