510(k) Report

510(k) · Cleared

Cleared

Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)

K140338510(k) TraditionalCleared Aug 27, 2014198-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

Creganna-Tactx Medical · DYB Introducer, Catheter

Cleared on Aug 27, 2014 as substantially equivalent to K093877 (Edwards Lifesciences, LLC, 2010) after a 198-day review. Its family tree reaches back 3 generations to 1990. 8 later devices descend from it.

Decided
Aug 27, 2014
Review
198 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K902469 (1990). 4 ancestors in all. 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2018: 1 descendant cleared2019: 2 descendants cleared2020: 2 descendants cleared2023: 2 descendants cleared2025: 1 descendant clearedK902469 · Byrd Dilator Sheath Set - Teflon · Medical Engineering and Development Institute · 1990K031087 · Edwards Introducer Sheath · Edwards Lifesciences, LLC · 2003K093877 · Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 · Edwards Lifesciences, LLC · 20101990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K093877 · Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26 · Edwards Lifesciences, LLC · 2010K031087 · Edwards Introducer Sheath · Edwards Lifesciences, LLC · 2003K902469 · Byrd Dilator Sheath Set - Teflon · Medical Engineering and Development Institute · 19900+5
  1. Root · 3 generations backK902469 Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute · 1990
  2. 2 generations backK031087 Edwards Introducer SheathEdwards Lifesciences, LLC · 2003
  3. 1 generation backK093877 Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC · 2010
  4. This deviceK140338 Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus…Creganna-Tactx Medical · 2014
  5. Descendant · cites it directly · 7 of its ownK180785 iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · Recalled
  6. Descendant · 2 generations on · 4 of its ownK191871 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · Recalled
  7. Descendant · 3 generations on · 2 of its ownK230051 14F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023 · Recalled
  8. Descendant · 4 generations on · 1 of its ownK233503 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2023 · Recalled
  9. Descendant · 5 generations on · 0 of its ownK250468 iSLEEVE Introducer SetBoston Scientific · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018: 12019: 22020: 22023: 22025: 1
2018high 2 (2019) · low 0 (2021)2026

Most influential descendants

Showing 5 of 8 · See all
  • K180785iSLEEVE Introducer SetBoston Scientific Corporation · 2018 · cites it directly7descendants
  • K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation · 2019 · 2 generations on4descendants
  • K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation · 2023 · 3 generations on2descendants
  • K23350314F iSLEEVE Introducer SetBoston Scientific Corporation · 2023 · 4 generations on1descendant
  • K250468iSLEEVE Introducer SetBoston Scientific · 2025 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K902469Byrd Dilator Sheath Set - TeflonMedical Engineering and Development Institute1990—
−2K031087Edwards Introducer SheathEdwards Lifesciences, LLC2003—
−1K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26Edwards Lifesciences, LLC2010—
0 (this device)K140338Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer…Creganna-Tactx Medical2014—
+1K180785iSLEEVE Introducer SetBoston Scientific Corporation20181
+2K19187115F iSLEEVE Introducer Set, 14F iSLEEVE Introducer SetBoston Scientific Corporation20191
+3K23005114F iSLEEVE™ Introducer SetBoston Scientific Corporation20231
+4K23350314F iSLEEVE Introducer SetBoston Scientific Corporation20231
+5K250468iSLEEVE Introducer SetBoston Scientific2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201920
202020
202320
202510
FIG. 1 — Lineage of K140338, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (1)

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
*K093877Retroflex 3 Introducer Sheath Set, Models 9120S23 and 9120S26
Summary page 4
…om Intended Use The LotusTM Introducer Set is intended to provide femoral access to the vascular system. Predicate Device RetroFlex3 Introducer Set cleared via 510(k) K093877. It is manufactured by Edwards Life Sciences. Device Description The LotusTM Introducer Set is a sterile, single-use introduce…
Edwards Lifesciences, LLC2010—

Also cleared against K093877: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K180785iSLEEVE Introducer SetBoston Scientific Corporation20187

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 24 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K180785 (Boston Scientific Corporation, 2018) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K093877.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Lotus Introducer Set is intended to provide femoral access to the vascular system.

Indications for use as stated in the FDA summary.

Also cleared against K093877

2 other devices cite the same predicate.

  • K152225Edwards eSheath Introducer SetEdwards Lifesciences · 2015
  • K141696Edwards Esheath Introducer SetEdwards Lifesciences · 2014

More from Creganna-Tactx Medical

2 FDA decisions under this applicant name. See the company

  • K110133Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterCreganna-Tactx Medical · 20113 recalls

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K140338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140338: Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140338

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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