510(k) Report

510(k) · Cleared

Cleared

Emcee Introducer Sheath, Dilator, Obturator, Introducer Set

K980504510(k) TraditionalCleared Aug 7, 1998179-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

Schneider/Namic · DYB Introducer, Catheter

Cleared on Aug 7, 1998 as substantially equivalent to K915078 (North American Instrument Corp., 1992) and 4 other predicates after a 179-day review. Its family tree reaches back 2 generations to 1981. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Aug 7, 1998
Review
179 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K810675 (1981). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1992: 1 other ancestor1990: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor1999: 1 descendant clearedK810675 · Arrow Radial Artery Catheterization Set · Arrow Intl., Inc. · 1981 · Class I recallK962746 · Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit · Cordis Corp. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant K962746 · Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit · Cordis Corp. · 1996K810675 · Arrow Radial Artery Catheterization Set · Arrow Intl., Inc. · 1981 · Class I recall0
  1. Root · 2 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
  2. 1 generation backK962746 Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996
  3. This deviceK980504 Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic · 1998
  4. Descendant · cites it directly · 0 of its ownK983039 Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set…Schneider/Namic · 1999

Class I recalls in this family

  • K810675 Arrow Radial Artery Catheterization Setdirect predicate · 1981

Most influential descendants

Showing 1 of 1 · See all
  • K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc.1981Class I
−1K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp.1996—
0 (this device)K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic1998—
+1K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee…Schneider/Namic1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199210
199310
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K980504, 1981–1999Source: 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.

1 device in this family has a Class I recall. 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? (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
*K915078Morse Hemostatic Catheter Introducer Set
Summary page 1
…de Name: Emcee Introducer Set Common Name: Catheter Introducer Classification Name: Introducer, Catheter Predicate Devices: MORSE® Hemostatic Catheter Introducer Set (K915078) Epic™ Introducer Sheath (K960310) Cook CHECK-FLO® Performer™ Introducer (K895044) Arrow Radial Artery Catheterization Set (K81…
North American Instrument Corp.1992—
*K960310Epic Introducer Sheath
Summary page 1
…on Name: Catheter Introducer Classification Name: Introducer, Catheter Predicate Devices: MORSE® Hemostatic Catheter Introducer Set (K915078) Epic™ Introducer Sheath (K960310) Cook CHECK-FLO® Performer™ Introducer (K895044) Arrow Radial Artery Catheterization Set (K810675) Cordis Avanti™ Transradial Sh…
North American Instrument Corp.1996—
*K895044Dual Guide Introducer Catheter
Summary page 1
…: Introducer, Catheter Predicate Devices: MORSE® Hemostatic Catheter Introducer Set (K915078) Epic™ Introducer Sheath (K960310) Cook CHECK-FLO® Performer™ Introducer (K895044) Arrow Radial Artery Catheterization Set (K810675) Cordis Avanti™ Transradial Sheath Kit (K962746) Product Description: _ The Em…
Cook, Inc.1990—
*K810675Arrow Radial Artery Catheterization Set
Summary page 1
…Hemostatic Catheter Introducer Set (K915078) Epic™ Introducer Sheath (K960310) Cook CHECK-FLO® Performer™ Introducer (K895044) Arrow Radial Artery Catheterization Set (K810675) Cordis Avanti™ Transradial Sheath Kit (K962746) Product Description: _ The Emcee™ Introducer Set is comprised of a percutaneous…
Arrow Intl., Inc.1981Class I
*K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit
Summary page 1
…ic™ Introducer Sheath (K960310) Cook CHECK-FLO® Performer™ Introducer (K895044) Arrow Radial Artery Catheterization Set (K810675) Cordis Avanti™ Transradial Sheath Kit (K962746) Product Description: _ The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may als…
Cordis Corp.1996—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic19990

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
  • 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K983039 (Schneider/Namic, 1999) has gone furthest, with 0 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)—

What is it indicated for?

Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Schneider/Namic

2 FDA decisions under this applicant name. See the company

  • K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath…Schneider/Namic · 1999

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/K980504 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980504: Emcee Introducer Sheath, Dilator, Obturator, Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980504

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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