510(k) Report

510(k) · Cleared

Recalled · 2006

Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

K001139510(k) SpecialCleared May 10, 200030-day reviewClass II21 CFR 870.1340Recalls 5

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

Biosense Webster, Inc. · DYB Introducer, Catheter

Cleared on May 10, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 5 times.

Decided
May 10, 2000
Review
30 days
Class
Class II
Product code
DYB
Recalls
5
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK001139 Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M…Biosense Webster, Inc. · 2000
  2. Descendant · cites it directly · 8 of its ownK101497 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · Recalled
  3. Descendant · 2 generations on · 7 of its ownK120459 Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012
  4. Descendant · 3 generations on · 6 of its ownK151951 Destino ReachOscor, Inc. · 2015
  5. Descendant · 4 generations on · 5 of its ownK240829 AuST Steerable SheathCenterPoint Systems, LLC · 2024
  6. Descendant · 5 generations on · 4 of its ownK242106 AuST Steerable SheathCenterPoint Systems, LLC · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12015: 12024: 22025: 12026: 3
2010high 3 (2026) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all
  • K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2010 · cites it directly8descendants
  • K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 2012 · 2 generations on7descendants
  • K151951Destino ReachOscor, Inc. · 2015 · 3 generations on6descendants
  • K240829AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 4 generations on5descendants
  • K242106AuST Steerable SheathCenterPoint Systems, LLC · 2024 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001139Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103MBiosense Webster, Inc.2000—
+1K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.201030
+2K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.2012—
+3K151951Destino ReachOscor, Inc.2015—
+4K240829AuST Steerable SheathCenterPoint Systems, LLC2024—
+5K242106AuST Steerable SheathCenterPoint Systems, LLC2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201510
202420
202510
202630
FIG. 1 — Lineage of K001139, 2000–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.20108

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 17, 2006Not classifiedZ-0541-2007OtherBiosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006Not classifiedZ-0540-2007OtherBiosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006Not classifiedZ-0537-2007OtherBiosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006Not classifiedZ-0538-2007OtherBiosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Nov 17, 2006Not classifiedZ-0539-2007OtherBiosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K101497 (Oscor, Inc., 2010) has gone furthest, with 8 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.

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)—

More from Biosense Webster, Inc.

638 FDA decisions under this applicant name. See the company

  • P030031/S146EZ Steer Thermocool Nav BI-Directional Electrophysiology Catheter; Thermocool Smarttouch BI-Directional…Biosense Webster, Inc. · 2026
  • P240006/S020Varipulse BI-Directional CatheterBiosense Webster, Inc. · 2026
  • P040036/S101Thermocool Smarttouch BI-Directional Navigation Catheter; Thermocool Smarttouch Uni-Directional Navigation…Biosense Webster, Inc. · 2026
  • P210027/S019Qdot Micro BI-Directional Navigation Catheter; Qdot Micro Uni-Directional Navigation CatheterBiosense Webster, Inc. · 2026
  • P210027/S018QDOT MICRO™ SystemBiosense Webster, Inc. · 2026

Recent decisions in DYB

The DYB category page

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https://510kreport.com/device/K001139 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001139: Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001139

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026