510(k) · Cleared

Recalled · 2004

Coaxial Dilator Set

K974640510(k) TraditionalCleared Mar 13, 199888-day reviewClass II21 CFR 870.1310Recalls 1

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

Boston Scientific Corp · DRE Dilator, Vessel, For Percutaneous Catheterization

Cleared on Mar 13, 1998 after an 88-day review. The FDA summary names its predicate without a number. 52 later devices descend from it. It has been recalled once.

Decided: Mar 13, 1998
Review: 88 days
Class: Class II
Product code: DRE
Recalls: 1
Predicates: 0

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

This deviceK974640 Coaxial Dilator SetBoston Scientific Corp · 1998
Descendant · cites it directly · 48 of its ownK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
Descendant · 2 generations on · 45 of its ownK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
Descendant · 3 generations on · 32 of its ownK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
Descendant · 4 generations on · 31 of its ownK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
Descendant · 3 generations on · 27 of its ownK081697 The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005…Access Scientific, Inc. · 2008

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

1999high 6 (2013) · low 0 (2001)2026

Most influential descendants

Showing 5 of 52 · 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

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K974640	Coaxial Dilator Set	Boston Scientific Corp	1998	—
+1	K990705	Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator…	Medamicus, Inc.	1999	1
+2	K071574	Stiffer Coaxial Micro-Introducer Kit	Enpath Medical, Inc.	2007	2
+3	K090372	The Wand Microaccess Safety Introducer	Access Scientific, Inc.	2009	—
+4	K093022	The Picc Wand Peelable Safety Introducer	Access Scientific, Inc.	2010	—
+3	K081697	The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006	Access Scientific, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2002	1	0
2007	1	0
2008	1	0
2009	1	0
2010	4	0
2011	4	0
2012	3	0
2013	6	0
2014	4	0
2015	3	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 K974640, 1998–2026Source: 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 DRE? 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 DRE device

#1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 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? (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	Applicant	Decided	Recalls
*	—	Coaxial dilator provided in Cook's Micropuncture Introducer Set Named without a submission number			—
*	—	Boston Scientific's peelable sheath and dilator Named without a submission number			—

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K990705	Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set	Medamicus, Inc.	1999	48
K123445	Nmi Coaxial Microintroducer Set	Navilyst Medical, Inc.	2013	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 5, 2004	Not classified	Z-0759-04	Other	Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

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 DRE devices

DRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRE

3in 2025

2007high 6 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRE

31in 2025

2007high 261 (2022) · low 30 (2015)2026

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

Recalls per year · DRE

1in 2016

2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRE

356in 2025

2007high 386 (2023) · low 38 (2008)2025

MAUDE reports naming product code DRE, 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	5	160	0	81
2008	2	—	0	38
2009	2	—	2	69
2010	1	—	2	73
2011	1	—	1	90
2012	1	—	0	132
2013	4	111	0	120
2014	6	72	0	82
2015	4	30	1	82
2016	3	90	1	84
2017	4	108	0	101
2018	2	—	0	126
2019	3	68	0	144
2020	3	30	0	120
2021	1	—	0	115
2022	3	261	0	136
2023	2	—	0	386
2024	1	—	0	325
2025	3	31	0	356
2026	1	—	1 (1)	—

What is it indicated for?

The coaxial dilator set is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a 21 Ga. needle stick.

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/K974640 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974640: Coaxial Dilator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974640

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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