510(k) · Decided
DecidedEmcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath Set, Emcee Inf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schneider/Namic · DYB Introducer, Catheter
Cleared on May 7, 1999 as substantially equivalent to K980504 (Schneider/Namic, 1998) and 1 other predicate after a 249-day review. Its family tree reaches back 3 generations to 1981. 1 of the 12 devices in its family, counting itself, has a Class I recall.
- Decided
- May 7, 1999
- Review
- 249 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810675 (1981). 11 ancestors in all. No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
- 2 generations backK962746 Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996
- 1 generation backK980504 Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic · 1998
- This deviceK983039 Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set…Schneider/Namic · 1999
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set2 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | 1981 | Class I |
| −2 | K962746 | Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit | Cordis Corp. | 1996 | — |
| −1 | K980504 | Emcee Introducer Sheath, Dilator, Obturator, Introducer Set | Schneider/Namic | 1998 | — |
| 0 (this device) | K983039 | Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee… | Schneider/Namic | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
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 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980504 | Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSummary page 1…Trade Name: Emcee™ Infusion Introducer Sheath Set Commeon Name: Catheter Introducer Classification Name: Introducer, Catheter Predicate Devices: Emcee™ Introducer Set (K980504) LocalMed™ InfusaSleeve™ 1I (K952317) Intended Use: The Emcee Infusion Introducer Sheath Set is intended for use in facilitati… | 1998 |
| * | K952317 | Kaplan-Simpson InfusaSleeve II CatheterSummary page 1…Sheath Set Commeon Name: Catheter Introducer Classification Name: Introducer, Catheter Predicate Devices: Emcee™ Introducer Set (K980504) LocalMed™ InfusaSleeve™ 1I (K952317) Intended Use: The Emcee Infusion Introducer Sheath Set is intended for use in facilitating the percutaneous introduction of ca… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (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. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983039: Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath Set, Emcee Inf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983039
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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