510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Delivery Sheath, Model Adelante Breezeway

K101497510(k) TraditionalCleared Oct 20, 2010141-day reviewClass II21 CFR 870.1340Recalls 30

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Oscor, Inc. · DYB Introducer, Catheter

Cleared on Oct 20, 2010 as substantially equivalent to K090114 (Oscor, Inc., 2009) and 4 other predicates after a 141-day review. Its family tree reaches back 4 generations to 1997. 8 later devices descend from it. It has been recalled 30 times.

Decided
Oct 20, 2010
Review
141 days
Class
Class II
Product code
DYB
Recalls
30
Predicates
5

Its longest line of descent runs back 4 generations to K964518 (1997). 18 ancestors in all, the oldest K924607 (1993). 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2000: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1998: 3 other ancestors1999: 1 other ancestor1993: 1 other ancestor2012: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 3 descendants clearedK964518 · Fast-Cath Transseptal Catheter Introducer · Daig Corp. · 1997 · recalledK042623 · Agilis Steerable Catheter Introducer, Model 408304 · St. Jude Medical, Daig Division, Inc. · 2005 · recalledK052644 · Swartz Braided Transseptal Guiding Introducer · St Jude Medical · 2005K061015 · Fast-Cath Hemostasis Introducer and Transseptal Introducer · St Jude Medical · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 1 descendant K061015 · Fast-Cath Hemostasis Introducer and Transseptal Introducer · St Jude Medical · 2006K052644 · Swartz Braided Transseptal Guiding Introducer · St Jude Medical · 2005K042623 · Agilis Steerable Catheter Introducer, Model 408304 · St. Jude Medical, Daig Division, Inc. · 2005 · recalledK964518 · Fast-Cath Transseptal Catheter Introducer · Daig Corp. · 1997 · recalled0+5
  1. Root · 4 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
  2. 3 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
  3. 2 generations backK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
  4. 1 generation backK061015 Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical · 2006
  5. This deviceK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010
  6. Descendant · cites it directly · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
  7. Descendant · 2 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
  8. Descendant · 3 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
  9. Descendant · 4 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024
  10. Descendant · 5 generations on · 3 of its ownK251051 AuST Steerable SheathCenterPoint Systems, LLC · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 12015: 12024: 22025: 12026: 3
2012high 3 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · cites it directly7descendants
  • K151951Destino ReachOscor, Inc. · 2015 · 2 generations on6descendants
  • K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 3 generations on5descendants
  • K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on4descendants
  • K251051AuST Steerable SheathCenterPoint Systems, LLC · 2025 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K964518Fast-Cath Transseptal Catheter IntroducerDaig Corp.19974
−3K042623Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc.20051
−2K052644Swartz Braided Transseptal Guiding IntroducerSt Jude Medical2005—
−1K061015Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical2006—
0 (this device)K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010—
+1K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.2012—
+2K151951Destino ReachOscor, Inc.2015—
+3K240829AuST Steerable SheathCenterPoint Systems, LLC2024—
+4K242106AuST Steerable SheathCenterPoint Systems, LLC2024—
+5K251051AuST Steerable SheathCenterPoint Systems, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199830
199910
200010
200120
200210
200410
200510
200820
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
202420
202510
202630
FIG. 1 — Lineage of K101497, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090114Modification to:Introducer Sets, Model Adelante and Adelante-S
Summary page 1
…3. Substantial Equivalence The Adelante® Breezeway is substantially equivalent to the following predicate devices: 1)Oscar Inc., Adelante" Sigma, Sigma AT and Targa, K090114 2) Boston Scientific, Convoy Advanced Delivery Sheath Kit, K07271 9 3) Thomas Medical, Reinforced Catheter Introducer sys…
Oscor, Inc.2009—
*K072719Convoy Advanced Delivery Sheath
Summary page 1
…ivalent to the following predicate devices: 1)Oscar Inc., Adelante" Sigma, Sigma AT and Targa, K090114 2) Boston Scientific, Convoy Advanced Delivery Sheath Kit, K07271 9 3) Thomas Medical, Reinforced Catheter Introducer system, K081341 4) Biosense Webster Inc., Preface Guiding Sheath, K001…
Boston Scientific Corp20081
*K081341Reinforced Catheter Introducer System (Rcis)
Summary page 1
…Sigma, Sigma AT and Targa, K090114 2) Boston Scientific, Convoy Advanced Delivery Sheath Kit, K07271 9 3) Thomas Medical, Reinforced Catheter Introducer system, K081341 4) Biosense Webster Inc., Preface Guiding Sheath, K001 139 5) St. Jude Medical, Fast-Cath Hemostasis and Transseptal Intr…
Thomas Medical Products, Inc.2008—
*K001139Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
Summary page 1
…Convoy Advanced Delivery Sheath Kit, K07271 9 3) Thomas Medical, Reinforced Catheter Introducer system, K081341 4) Biosense Webster Inc., Preface Guiding Sheath, K001 139 5) St. Jude Medical, Fast-Cath Hemostasis and Transseptal Introducer, K061015 4. Device Description The Adelante® Breezeway D…
Biosense Webster, Inc.20005
*K061015Fast-Cath Hemostasis Introducer and Transseptal Introducer
Summary page 1
…heter Introducer system, K081341 4) Biosense Webster Inc., Preface Guiding Sheath, K001 139 5) St. Jude Medical, Fast-Cath Hemostasis and Transseptal Introducer, K061015 4. Device Description The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any of t…
St Jude Medical2006—

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 5, 2016Class IIZ-0796-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0798-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0800-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0805-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0806-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0810-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0792-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0793-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0795-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0797-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0799-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0803-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0790-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0791-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0794-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0802-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0804-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0811-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0812-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0813-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0814-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0816-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0818-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0801-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0807-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0808-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0809-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0815-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0817-2017Nonconforming Material/ComponentComplaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016Class IIZ-0819-2017Nonconforming Material/ComponentComplaint 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 13 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • 11 of the 18 ancestors have a recall of any class.
  • Of its descendants, K120459 (Oscor, Inc., 2012) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
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

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

Indications for use as stated in the FDA summary.

More from Oscor, Inc.

49 FDA decisions under this applicant name. See the company

  • K210627Breezeway IIOscor, Inc. · 2021
  • K151951Destino ReachOscor, Inc. · 2015
  • K143463IS4/DF4 Port PlugOscor, Inc. · 2015
  • K140917Introducer, Model Adelante MagnumOscor, Inc. · 2014
  • K140406Destino Twist, Steerable Guiding SheathOscor, Inc. · 20141 recall

Recent decisions in DYB

The DYB category page

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https://510kreport.com/device/K101497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101497: 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/K101497

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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