510(k) Report

510(k) · Cleared

Cleared

Percutaneous Introducer

K932323510(k) TraditionalCleared Nov 9, 1993182-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

Medamicus, Inc. · DYB Introducer, Catheter

Cleared on Nov 9, 1993 after a 182-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 67 later devices descend from it.

Decided
Nov 9, 1993
Review
182 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 2 descendants cleared1999: 1 descendant cleared2003: 1 descendant cleared2000: 1 descendant cleared2007: 2 descendants cleared2011: 4 descendants cleared2010: 5 descendants cleared2004: 2 descendants cleared2009: 2 descendants cleared2008: 1 descendant cleared2013: 5 descendants cleared2018: 3 descendants cleared2014: 4 descendants cleared2012: 6 descendants cleared2006: 1 descendant cleared2016: 7 descendants cleared2017: 3 descendants cleared2015: 3 descendants cleared2024: 3 descendants cleared2026: 1 descendant cleared2020: 2 descendants cleared2022: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2025: 3 descendants cleared1990200020102020
  1. This deviceK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
  2. Descendant · cites it directly · 48 of its ownK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 45 of its ownK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 32 of its ownK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
  5. Descendant · 4 generations on · 31 of its ownK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
  6. Descendant · 3 generations on · 27 of its ownK081697 The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005…Access Scientific, Inc. · 2008

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12002: 22003: 12004: 22006: 12007: 22008: 12009: 22010: 52011: 42012: 62013: 52014: 42015: 32016: 72017: 32018: 32019: 12020: 22021: 22022: 22024: 32025: 32026: 1
1999high 7 (2016) · low 0 (2001)2026

Most influential descendants

Showing 5 of 67 · See all
  • K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetMedamicus, Inc. · 1999 · cites it directly48descendants
  • K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · 2 generations on45descendants
  • K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009 · 3 generations on32descendants
  • K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010 · 4 generations on31descendants
  • K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc. · 2008 · 3 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932323Percutaneous IntroducerMedamicus, Inc.1993—
+1K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator…Medamicus, Inc.19991
+2K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc.20072
+3K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc.2009—
+4K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.2010—
+3K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200220
200310
200420
200610
200720
200810
200920
201050
201140
201260
201350
201440
201530
201670
201730
201830
201910
202020
202120
202220
202430
202530
202610
FIG. 1 — Lineage of K932323, 1993–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetMedamicus, Inc.199948
K021004Valved Peelable IntroducerMedamicus, Inc.200221

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, K990705 (Medamicus, Inc., 1999) has gone furthest, with 48 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 Medamicus, Inc.

20 FDA decisions under this applicant name. See the company

  • K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
  • K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
  • K022689Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
  • K021004Valved Peelable IntroducerMedamicus, Inc. · 2002
  • K020563Medamicus Axia RSNMedamicus, Inc. · 2002

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/K932323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932323: Percutaneous Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932323

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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