510(k) · Cleared

Cleared

HI-Torque Command Guide Wire Family

K122573510(k) TraditionalCleared Nov 20, 201289-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 Nov 20, 2012 as substantially equivalent to K072460 (Abbott Vascular, Inc., 2008) and 4 other predicates after an 89-day review. Its family tree reaches back 7 generations to 1991. 2 of the 29 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided: Nov 20, 2012
Review: 89 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K913353 (1991). 22 ancestors in all. 6 later devices descend from it, 5 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
6 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
5 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
4 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
3 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
2 generations backK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
1 generation backK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
This deviceK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
Descendant · cites it directly · 1 of its ownK240997 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2024
Descendant · cites it directly · 1 of its ownK152404 Hi-Torque Command 18 Guide WireAbbott Vascular · 2015
Descendant · 2 generations on · 0 of its ownK250552 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2025
Descendant · cites it directly · 0 of its ownK191502 Heraeus Peripheral GuidewireHeraeus Medical Components, LLC · 2019
Descendant · cites it directly · 0 of its ownK172073 Hi-Torque Command 18 Guide WireAbbott Vascular · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014high 1 (2014) · low 0 (2016)2026

Class I recalls in this family

K091582 GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 152 generations back · 2009
K970466 Radius Ptca Guidewire3 generations back · 1997

Most influential descendants

Showing 5 of 6 · See all

K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2024 · cites it directly1descendant
K152404Hi-Torque Command 18 Guide WireAbbott Vascular · 2015 · cites it directly1descendant
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2025 · 2 generations on0descendants
K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC · 2019 · cites it directly0descendants
K172073Hi-Torque Command 18 Guide WireAbbott Vascular · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K913353	Vascular Guide Wire	Advanced Cardiovascular Systems, Inc.	1991	—
−6	K971815	Asc Balance Middleweight Guide Wire	Guidant Corp.	1997	—
−5	K973494	HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque…	Guidant Corp.	1997	—
−4	K013833	HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic…	Guidant Corp.	2002	—
−3	K072460	HI-Torque Balance Middleweight Universal II Guide Wire	Abbott Vascular, Inc.	2008	—
−2	K103101	HI-Torque Balance Middleweight Elite	Abbott Vascular-Cardiac Therapies	2011	—
−1	K112957	HI-Torque Powerturn	Abbott Vascular-Cardiac Therapies	2011	—
0 (this device)	K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	—
+1	K240997	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	Abbott Medical	2024	—
+1	K152404	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2015	—
+2	K250552	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	Abbott Medical	2025	—
+1	K191502	Heraeus Peripheral Guidewire	Heraeus Medical Components, LLC	2019	—
+1	K172073	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	2	0
1996	1	0
1997	1	1
2000	2	0
2001	1	0
2002	2	0
2003	1	0
2006	1	0
2007	1	0
2009	1	1
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2017	1	0
2019	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K122573, 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.

2 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K072460	HI-Torque Balance Middleweight Universal II Guide Wire Summary page 1 …Catheter Guide Wire (DQX) 10. Predicate Device(s) Name HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 11 Guide Wire (K072460, cleared April 11, 2008); HI-TORQUE BALANCE HEAVY…	Abbott Vascular, Inc.	2008	—
*	K021228	HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the… Summary page 1 …UNIVERSAL 11 Guide Wire (K072460, cleared April 11, 2008); HI-TORQUE BALANCE HEAVYWEIGHT (K02 1228, cleared May 15, 2002), HI-TORQUE BMW ELITE (K103101,…	Guidant Corp.	2002	—
*	K103101	HI-Torque Balance Middleweight Elite Summary page 1 …08); HI-TORQUE BALANCE HEAVYWEIGHT (K02 1228, cleared May 15, 2002), HI-TORQUE BMW ELITE (K103101, cleared Feb. 10, 2011), HI-TORQUE WHISPER, (Ki0l…	Abbott Vascular-Cardiac Therapies	2011	—
*	K101116	HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Abbott Vascular-Cardiac Therapies	2010	—
*	K112957	HI-Torque Powerturn	Abbott Vascular-Cardiac Therapies	2011	—

Also cleared against K072460: 4 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K240997	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	Abbott Medical	2024	1
K152404	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2015	1
K191502	Heraeus Peripheral Guidewire	Heraeus Medical Components, LLC	2019	0
K172073	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2017	0
K142415	Hi-Torque JET Guide Wire Family	Abbott Vascular, Inc.	2014	0

Has anything in its family been recalled? (2 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.

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

What does this lineage say?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
3 of the 22 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K240997 (Abbott Medical, 2024) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K072460.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 translumrinal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The guide wire may also be used to reach and cross a target lesion, provide a pathway within a vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122573 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122573: HI-Torque Command Guide Wire Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122573

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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