510(k) · Cleared

Cleared

Medtronic GT2 Fusion Guide Wires

K992237510(k) SpecialCleared Sep 9, 199969-day reviewClass II21 CFR 870.1330

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

Medtronic Vascular · DQX Wire, Guide, Catheter

Cleared on Sep 9, 1999 as substantially equivalent to K983927 (Arterial Vascular Engineering, Inc., 1999) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1989. 1 of the 5 devices in its family, counting itself, has a Class I recall.

Decided: Sep 9, 1999
Review: 69 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K890505 (1989). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
1 generation backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
This deviceK992237 Medtronic GT2 Fusion Guide WiresMedtronic Vascular · 1999

Class I recalls in this family

K983927 GT1 Floppy, GT1 HI-Per Flex, GT1 Light Supportdirect predicate · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K890505	Usci Grey/Black Guide Wire	C.R. Bard, Inc.	1989	—
−1	K961271	Usci Commander Series Guide Wires	C.R. Bard, Inc.	1996	—
0 (this device)	K992237	Medtronic GT2 Fusion Guide Wires	Medtronic Vascular	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	1

FIG. 1 — Lineage of K992237, 1989–1999Source: 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.

1 device in this family has 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? (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	Applicant	Decided	Recalls
*	K983927	GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support Summary page 1 …adequate for the intended use. The Medtronic™ GT2 Fusion Guide Wire is considered to be substantially equivalent to the following devices: e Medtronic GT1 Guide Wire (K983927) ¢ Bard Hydrophilic Coated Guide Wire (K974713) e USCI Commander Series Guide Wires (K961271) 030 »* L ada* 7…	Arterial Vascular Engineering, Inc.	1999	Class I
*	K974713	Bard Hydrophillic Coated Guide Wire Summary page 1 …T2 Fusion Guide Wire is considered to be substantially equivalent to the following devices: e Medtronic GT1 Guide Wire (K983927) ¢ Bard Hydrophilic Coated Guide Wire (K974713) e USCI Commander Series Guide Wires (K961271) 030 »* L ada* 7 é‘a-mrn, % ' . . C DEPARTMENT OF HEALTH & HUMA…	C.R. Bard, Inc.	1998	—
*	K961271	Usci Commander Series Guide Wires Summary page 1 …ntially equivalent to the following devices: e Medtronic GT1 Guide Wire (K983927) ¢ Bard Hydrophilic Coated Guide Wire (K974713) e USCI Commander Series Guide Wires (K961271) 030 »* L ada* 7 é‘a-mrn, % ' . . C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service *tren Food and…	C.R. Bard, Inc.	1996	—
*	—	AVE GT1 Guide Wire Named without a submission number			—

Also cleared against K983927: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

K983927GT1 Floppy, GT1 HI-Per Flex, GT1 Light SupportArterial Vascular Engineering, Inc. · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
3 other devices also cite its predicate K983927.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

GT2 Fusion 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. The GT2 Fusion Guide Wires are not intended for use in the cerebral vasculature. GT2 Fusion steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another

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/K992237 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992237: Medtronic GT2 Fusion Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992237

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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