510(k) · Cleared

Recalled · Class II · 2016

Stiffer Coaxial Micro-Introducer Kit

K071574510(k) SpecialCleared Jul 5, 200727-day reviewClass II21 CFR 870.1340Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Enpath Medical, Inc. · DYB Introducer, Catheter

Cleared on Jul 5, 2007 as substantially equivalent to K990705 (Medamicus, Inc., 1999) after a 27-day review. Its family tree reaches back 2 generations to 1993. 45 later devices descend from it. It has been recalled 2 times.

Decided: Jul 5, 2007
Review: 27 days
Class: Class II
Product code: DYB
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K932323 (1993). 3 ancestors in all. 45 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
1 generation backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
This deviceK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007
Descendant · cites it directly · 32 of its ownK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
Descendant · 2 generations on · 31 of its ownK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
Descendant · cites it directly · 27 of its ownK081697 The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005…Access Scientific, Inc. · 2008
Descendant · 2 generations on · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
Descendant · 3 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2008high 5 (2016) · low 0 (2023)2026

Most influential descendants

Showing 5 of 45 · See all

K090372The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009 · cites it directly32descendants
K093022The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010 · 2 generations on31descendants
K081697The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006Access Scientific, Inc. · 2008 · cites it directly27descendants
K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · 2 generations on25descendants
K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K932323	Percutaneous Introducer	Medamicus, Inc.	1993	—
−1	K990705	Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator…	Medamicus, Inc.	1999	1
0 (this device)	K071574	Stiffer Coaxial Micro-Introducer Kit	Enpath Medical, Inc.	2007	—
+1	K090372	The Wand Microaccess Safety Introducer	Access Scientific, Inc.	2009	—
+2	K093022	The Picc Wand Peelable Safety Introducer	Access Scientific, Inc.	2010	—
+1	K081697	The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006	Access Scientific, Inc.	2008	—
+2	K101422	The Power Wand Safety Introducer with an Extended Dwell Catheter	Access Scientific, Inc.	2011	—
+3	K121073	Powerglide Midline Catheter	C.R. Bard, Inc.	2012	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	4	0
2011	4	0
2012	3	0
2013	4	0
2014	4	0
2015	2	0
2016	5	0
2017	2	0
2018	3	0
2019	1	0
2020	1	0
2021	2	0
2022	2	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K071574, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K990705	Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set Summary page 1 …standards applicable tot his product have been developed under Section 514 of the Act. Predicate Device Enpath Medical, Inc. Coaxial Micro-Introducer Set (K990705) Device Description The Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injecti…	Medamicus, Inc.	1999	1

Also cleared against K990705: 3 other devices →

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K090372	The Wand Microaccess Safety Introducer	Access Scientific, Inc.	2009	32
K081697	The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006	Access Scientific, Inc.	2008	27
K101604	Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V, 7259V…	Vascular Solutions, Inc.	2011	6
K091954	Micro-Stick Set	Medcomp	2010	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 8, 2016	Class II	Z-0051-2017	Nonconforming Material/Component	The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
Sep 8, 2016	Class II	Z-0623-2017	Process design	Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
2 of the 3 ancestors have a recall of any class.
Of its descendants, K090372 (Access Scientific, Inc., 2009) has gone furthest, with 32 descendants of its own.
3 other devices also cite its predicate K990705.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

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

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

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?

The Stiffer Coaxial Micro-Introducer Kit 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 as stated in the FDA summary.

https://510kreport.com/device/K071574 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071574: Stiffer Coaxial Micro-Introducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071574

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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