510(k) Report

510(k) · Cleared

Cleared

Epic Introducer Sheath

K960310510(k) TraditionalCleared Feb 7, 199616-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

North American Instrument Corp. · DYB Introducer, Catheter

Cleared on Feb 7, 1996 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 7, 1996
Review
16 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960310 Epic Introducer SheathNorth American Instrument Corp. · 1996
  2. Descendant · cites it directly · 1 of its ownK980504 Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic · 1998
  3. Descendant · 2 generations on · 0 of its ownK983039 Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set…Schneider/Namic · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic · 1998 · cites it directly1descendant
  • K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion…Schneider/Namic · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960310Epic Introducer SheathNorth American Instrument Corp.1996—
+1K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic1998—
+2K983039Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee…Schneider/Namic1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
FIG. 1 — Lineage of K960310, 1996–1999Source: 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), 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?

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

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K980504Emcee Introducer Sheath, Dilator, Obturator, Introducer SetSchneider/Namic19981

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, K980504 (Schneider/Namic, 1998) has gone furthest, with 1 descendant 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 North American Instrument Corp.

28 FDA decisions under this applicant name. See the company

  • K960801Selector Angiographic Catheter (Various Models)North American Instrument Corp. · 1996
  • K955554Hemo-ValveNorth American Instrument Corp. · 1996
  • K922552Morse (R) Angiographic CathetersNorth American Instrument Corp. · 1993
  • K915078Morse Hemostatic Catheter Introducer SetNorth American Instrument Corp. · 1992
  • K905208Morse AnesthesiaNorth American Instrument Corp. · 1992

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The DYB category page

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https://510kreport.com/device/K960310 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960310: Epic Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960310

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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