510(k) · Cleared

Cleared

HI-Torque Balance Middleweight Universal II Guide Wire

K072460510(k) TraditionalCleared Apr 11, 2008224-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

Abbott Vascular, Inc. · DQX Wire, Guide, Catheter

Cleared on Apr 11, 2008 as substantially equivalent to K013833 (Guidant Corp., 2002) after a 224-day review. Its family tree reaches back 4 generations to 1991. 1 of the 29 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it.

Decided: Apr 11, 2008
Review: 224 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K913353 (1991). 7 ancestors in all. 21 later devices descend from it, 5 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
3 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
2 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
1 generation backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
This deviceK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
Descendant · cites it directly · 13 of its ownK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
Descendant · cites it directly · 9 of its ownK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009
Descendant · 2 generations on · 7 of its ownK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
Descendant · cites it directly · 6 of its ownK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
Descendant · cites it directly · 4 of its ownK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2009high 3 (2019) · low 0 (2016)2026

Class I recalls in this family

K121398 Charlie Guidewire (Regular), Charlie Guidewire…2 generations on · 2012

Most influential descendants

Showing 5 of 21 · See all

K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011 · cites it directly13descendants
K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009 · cites it directly9descendants
K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011 · 2 generations on7descendants
K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · cites it directly6descendants
K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K913353	Vascular Guide Wire	Advanced Cardiovascular Systems, Inc.	1991	—
−3	K971815	Asc Balance Middleweight Guide Wire	Guidant Corp.	1997	—
−2	K973494	HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque…	Guidant Corp.	1997	—
−1	K013833	HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic…	Guidant Corp.	2002	—
0 (this device)	K072460	HI-Torque Balance Middleweight Universal II Guide Wire	Abbott Vascular, Inc.	2008	—
+1	K103101	HI-Torque Balance Middleweight Elite	Abbott Vascular-Cardiac Therapies	2011	—
+1	K091825	HI-Torque Progress Guide Wire Family	Abbott Vascular, Inc.	2009	—
+2	K112957	HI-Torque Powerturn	Abbott Vascular-Cardiac Therapies	2011	—
+1	K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	—
+1	K101011	HI-Torque Balance Middleweight Universal	Abbott Vascular, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	2	0
2012	2	1
2013	1	0
2014	2	0
2015	2	0
2017	2	0
2018	1	0
2019	3	0
2020	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K072460, 1991–2025Source: 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

Get a 510(k) Report

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
*	K013833	HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating… Summary page 1 …ication Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire (K013833, cleared Jan 16, 2002) 11. Device Description The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL…	Guidant Corp.	2002	—

Also cleared against K013833: 5 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K103101	HI-Torque Balance Middleweight Elite	Abbott Vascular-Cardiac Therapies	2011	13
K091825	HI-Torque Progress Guide Wire Family	Abbott Vascular, Inc.	2009	9
K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	6
K101011	HI-Torque Balance Middleweight Universal	Abbott Vascular, Inc.	2010	4
K152709	HI-Torque Balance	Abbott Vascular	2015	2

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.

K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls

What does this lineage say?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K103101 (Abbott Vascular-Cardiac Therapies, 2011) has gone furthest, with 13 descendants of its own.
5 other devices also cite its predicate K013833.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072460 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072460: HI-Torque Balance Middleweight Universal II Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072460

Report an extraction error

Are you the manufacturer?

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