510(k) · Cleared

Recalled · Class I · 2013

GTX 12 Gidewire

K100470510(k) SpecialCleared Apr 21, 201062-day reviewClass II21 CFR 870.1330Recalls 1 (1 Class I)

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

Medtronic, Inc. · DQX Wire, Guide, Catheter

Cleared on Apr 21, 2010 as substantially equivalent to K091582 (Medtronic Vascular, 2009) after a 62-day review. Its family tree reaches back 2 generations to 1997. 3 of the 5 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.

Decided: Apr 21, 2010
Review: 62 days
Class: Class II
Product code: DQX
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 2 generations to K970466 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK970466 Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · Recalled (Class I)
1 generation backK091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · Recalled (Class I)
This deviceK100470 GTX 12 GidewireMedtronic, Inc. · 2010
Descendant · cites it directly · 0 of its ownK140695 Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia…Medtronic, Inc. · 2014

Class I recalls in this family

K091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15direct predicate · 2009
K970466 Radius Ptca Guidewire2 generations back · 1997

Most influential descendants

Showing 1 of 1 · See all

K140695Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…Medtronic, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970466	Radius Ptca Guidewire	Radius Medical Technologies, Inc.	1997	Class I
−1	K091582	GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15	Medtronic Vascular	2009	Class I
0 (this device)	K100470	GTX 12 Gidewire	Medtronic, Inc.	2010	—
+1	K140695	Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire…	Medtronic, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K100470, 1997–2014Source: 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.

3 devices in this family have a Class I recall. 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 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
*	K091582	GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 Summary page 1 …PTCA Guidewire Classification Wire, Guide, Cardiovascular Name: 21 CFR 1330, Product Code DQX Predicate Devices: Medtronic GTX Guidewire (K091582) Device The Medtronic GTX 12 guidewires are available in Description: nominal 180cm length and 300cm exch…	Medtronic Vascular	2009	Class I
†	K032899	Radius Cougar Wire	Radius Medical Technologies, Inc.	2003	Class I
†	K983927	GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support	Arterial Vascular Engineering, Inc.	1999	Class I

Also cleared against K091582: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140695	Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…	Medtronic, Inc.	2014	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 21, 2013	Class I	Z-0264-2014	Nonconforming Material/Component	Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K140695 (Medtronic, Inc., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K091582.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100470 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100470: GTX 12 Gidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100470

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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