510(k) · Cleared

Cleared

Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013

K031173510(k) TraditionalCleared Jul 23, 2003100-day reviewClass I21 CFR 878.4800

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

Needle Tech Products, Inc. · GDF Guide, Needle, Surgical

Cleared on Jul 23, 2003 after a 100-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.

Decided: Jul 23, 2003
Review: 100 days
Class: Class I
Product code: GDF
Recalls: None
Predicates: 0

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

This deviceK031173 Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053…Needle Tech Products, Inc. · 2003
Descendant · cites it directly · 1 of its ownK040029 Safetynet Guidewire IntroducerInjectimed, Inc. · 2004
Descendant · cites it directly · 0 of its ownK101312 Nuvue COLORMARK9TM) NeedleNuvue Therapeutics, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK073664 Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008

Most influential descendants

Showing 3 of 3 · See all

K040029Safetynet Guidewire IntroducerInjectimed, Inc. · 2004 · cites it directly1descendant
K101312Nuvue COLORMARK9TM) NeedleNuvue Therapeutics, Inc. · 2011 · cites it directly0descendants
K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031173	Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 &…	Needle Tech Products, Inc.	2003	—
+1	K040029	Safetynet Guidewire Introducer	Injectimed, Inc.	2004	—
+1	K101312	Nuvue COLORMARK9TM) Needle	Nuvue Therapeutics, Inc.	2011	—
+2	K073664	Frontline Medical Safetynet Guidewire Introducer	Injectimed, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2011	1	0

FIG. 1 — Lineage of K031173, 2003–2011Source: 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 GDF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (4)

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	Recalls
*	—	Terumo Neolus Needle Named without a submission number	—
*	—	Medtronic Disposable Hypodermic Needle Electrode Named without a submission number	—
*	—	MNUL4.D Light Saber Introducer Needle Named without a submission number	—
*	—	Manan Blunt Needle Named without a submission number	—

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K040029	Safetynet Guidewire Introducer	Injectimed, Inc.	2004	1
K101312	Nuvue COLORMARK9TM) Needle	Nuvue Therapeutics, Inc.	2011	0

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, K040029 (Injectimed, Inc., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GDF devices

GDF Guide, Needle, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDF

FDA has decided no GDF device since 2007.

Median 510(k) review, days · GDF

Too few GDF 510(k)s in any year since 2007 to give a median.

Recalls per year · GDF

4in 2016

2007high 6 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GDF

19in 2025

2007high 19 (2025) · low 2 (2008)2025

MAUDE reports naming product code GDF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	6	9
2008	—	0	2
2009	—	1	6
2010	—	1	6
2011	—	0	9
2012	—	0	10
2013	—	0	9
2014	—	0	7
2015	—	0	18
2016	—	4	15
2017	—	0	6
2018	—	0	7
2019	—	0	13
2020	—	0	14
2021	—	0	9
2022	—	0	4
2023	—	0	13
2024	—	0	16
2025	—	0	19
2026	—	0	—

What is it indicated for?

The guidewire introducer needles are intended for use as introducershnnula for percutaneous introduction and placement of guidewires in vascular procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031173 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031173: Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031173

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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