510(k) Report

510(k) · Cleared

Cleared

Ultimum Hemostasis Introducer, Model 4076XX

K001346510(k) SpecialCleared May 24, 200026-day reviewClass II21 CFR 870.1340

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

St. Jude Medical, Inc. · DYB Introducer, Catheter

Cleared on May 24, 2000 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 24, 2000
Review
26 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared200020052010201520202025
  1. This deviceK001346 Ultimum Hemostasis Introducer, Model 4076XXSt. Jude Medical, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK091137 Ultimum/Engage/Engage TRSt Jude Medical · 2009 · Recalled
  3. Descendant · cites it directly · 0 of its ownK093130 Engage TR IntroducerSt Jude Medical · 2009 · Recalled
  4. Descendant · cites it directly · 0 of its ownK092575 Engage/Engage TRSt Jude Medical · 2009 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K091137Ultimum/Engage/Engage TRSt Jude Medical · 2009 · cites it directly2descendants
  • K093130Engage TR IntroducerSt Jude Medical · 2009 · cites it directly0descendants
  • K092575Engage/Engage TRSt Jude Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001346Ultimum Hemostasis Introducer, Model 4076XXSt. Jude Medical, Inc.2000—
+1K091137Ultimum/Engage/Engage TRSt Jude Medical20095
+1K093130Engage TR IntroducerSt Jude Medical20095
+1K092575Engage/Engage TRSt Jude Medical20095

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
FIG. 1 — Lineage of K001346, 2000–2009Source: 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? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091137Ultimum/Engage/Engage TRSt Jude Medical20092
K093130Engage TR IntroducerSt Jude Medical20090
K092575Engage/Engage TRSt Jude Medical20090

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?

  • Of its descendants, K091137 (St Jude Medical, 2009) has gone furthest, with 2 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 St. Jude Medical, Inc.

353 FDA decisions under this applicant name. See the company

  • K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
  • K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 20174 recalls
  • K161171PressureWire X GuidewireSt. Jude Medical, Inc. · 2016
  • K161102Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
  • K160716The Nanostim Introducer KitSt. Jude Medical, Inc. · 2016

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https://510kreport.com/device/K001346 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001346: Ultimum Hemostasis Introducer, Model 4076XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001346

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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