510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set

K990705510(k) TraditionalCleared Jun 28, 1999116-day reviewClass II21 CFR 870.1340Recalls 1

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 Jun 28, 1999 as substantially equivalent to K932323 (Medamicus, Inc., 1993) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1993. 48 later devices descend from it. It has been recalled once.

Decided
Jun 28, 1999
Review
116 days
Class
Class II
Product code
DYB
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K932323 (1993). 2 ancestors in all. 48 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2000: 1 descendant cleared2007: 1 descendant cleared2011: 4 descendants cleared2010: 4 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2013: 4 descendants cleared2018: 3 descendants cleared2014: 4 descendants cleared2002: 1 descendant cleared2012: 3 descendants cleared2016: 5 descendants cleared2017: 2 descendants cleared2024: 2 descendants cleared2026: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2022: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2025: 3 descendants clearedK932323 · Percutaneous Introducer · Medamicus, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 8 descendants6 generations forward: 6 descendants7 generations forward: 5 descendants8 generations forward: 5 descendants9 generations forward: 2 descendants K932323 · Percutaneous Introducer · Medamicus, Inc. · 19930+5
  1. Root · 1 generation backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
  2. This deviceK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999
  3. Descendant · cites it directly · 45 of its ownK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 32 of its ownK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
  5. Descendant · 3 generations on · 31 of its ownK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
  6. Descendant · 2 generations on · 27 of its ownK081697 The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005…Access Scientific, Inc. · 2008
  7. Descendant · 3 generations on · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12007: 12008: 12009: 12010: 42011: 42012: 32013: 42014: 42015: 22016: 52017: 22018: 32019: 12020: 12021: 22022: 22024: 22025: 32026: 1
2000high 5 (2016) · low 0 (2001)2026

Most influential descendants

Showing 5 of 48 · See all
  • K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · cites it directly45descendants
  • K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009 · 2 generations on32descendants
  • K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010 · 3 generations on31descendants
  • K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc. · 2008 · 2 generations on27descendants
  • K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · 3 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K932323Percutaneous IntroducerMedamicus, Inc.1993—
0 (this device)K990705Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator…Medamicus, Inc.1999—
+1K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc.20072
+2K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc.2009—
+3K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc.2010—
+2K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc.2008—
+3K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200710
200810
200910
201040
201140
201230
201340
201440
201520
201650
201720
201830
201910
202010
202120
202220
202420
202530
202610
FIG. 1 — Lineage of K990705, 1993–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K932323Percutaneous Introducer
Summary page 1
…MN 55447 Contact Dennis S. Madison Vice President, Quality Assurance/Regulatory Affairs 612-559-2613 Predicate Devices Percutaneous Introducers from MedAmicus, Inc. (K932323) Coaxial Introducers from Boston Scientific, Inc. (K974640) Device Description Information Intended Use The MedAmicus Coaxial…
Medamicus, Inc.1993—
*K974640Coaxial Dilator Set
Summary page 1
…y Assurance/Regulatory Affairs 612-559-2613 Predicate Devices Percutaneous Introducers from MedAmicus, Inc. (K932323) Coaxial Introducers from Boston Scientific, Inc. (K974640) Device Description Information Intended Use The MedAmicus Coaxial Introducer is intended to be used in the exact same manner…
Boston Scientific Corp19981

Also cleared against K932323: 1 other device →

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K071574Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc.200745
K101604Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V…Vascular Solutions, Inc.20116
K091954Micro-Stick SetMedcomp20103
K994097Medamicus Epidural IntroducerMedamicus, Inc.20001

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 28, 2014Class IIZ-1614-2014Incorrect or no expiration dateGreatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K071574 (Enpath Medical, Inc., 2007) has gone furthest, with 45 descendants of its own.
  • 1 other device also cites its predicate K932323.

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?

The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

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

Also cleared against K932323

1 other device cites the same predicate.

  • K021004Valved Peelable IntroducerMedamicus, Inc. · 2002

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/K990705 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990705

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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