510(k) · Cleared

Cleared

HI-Torque Powerturn

K112957510(k) TraditionalCleared Nov 8, 201135-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-Cardiac Therapies · DQX Wire, Guide, Catheter

Cleared on Nov 8, 2011 as substantially equivalent to K060449 (Guidant Corporation, 2006) and 2 other predicates after a 35-day review. Its family tree reaches back 6 generations to 1991. 2 of the 24 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.

Decided: Nov 8, 2011
Review: 35 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K913353 (1991). 16 ancestors in all. 7 later devices descend from it, 2 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
5 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
4 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
3 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
2 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
1 generation backK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
This deviceK112957 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 · 2 generations on · 1 of its ownK240997 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2024
Descendant · 2 generations on · 1 of its ownK152404 Hi-Torque Command 18 Guide WireAbbott Vascular · 2015
Descendant · 3 generations on · 0 of its ownK250552 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2025
Descendant · 2 generations on · 0 of its ownK191502 Heraeus Peripheral GuidewireHeraeus Medical Components, LLC · 2019

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012high 1 (2012) · low 0 (2013)2026

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 5 of 7 · See all

K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · cites it directly6descendants
K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2024 · 2 generations on1descendant
K152404Hi-Torque Command 18 Guide WireAbbott Vascular · 2015 · 2 generations on1descendant
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2025 · 3 generations on0descendants
K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

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
2006	1	0
2007	1	0
2009	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2015	1	0
2017	1	0
2019	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K112957, 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? (3)

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
*	K060449	HI-Torque Advance and Advance Lite Guide Wire Summary page 1 …Classification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE ADVANCE and ADVANCE LITE (K060449, cleared May 30, 2006), HI-TORQUE BALANCE MIDDLEWEIGHT ELITE (K 103 10 1,…	Guidant Corporation	2006	—
*	K103101	HI-Torque Balance Middleweight Elite Summary page 1 …NCE and ADVANCE LITE (K060449, cleared May 30, 2006), HI-TORQUE BALANCE MIDDLEWEIGHT ELITE (K 103 10 1, cleared Feb. 10, 2011), and Medtronic Vascular GTX…	Abbott Vascular-Cardiac Therapies	2011	—
*	K091582	GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 Summary page 1 …DLEWEIGHT ELITE (K 103 10 1, cleared Feb. 10, 2011), and Medtronic Vascular GTX Guide Wire, K0915 82, cleared Dee. 4, 2009) 11. Device Description The HI-TORQUE POWERTURN Guide Wire Family has a diameter of 0.014" with a 190 cm…	Medtronic Vascular	2009	Class I

Also cleared against K060449: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	6
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 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
3 of the 16 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K122573 (Abbott Vascular, Inc., 2012) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K060449.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 delivery of catheter-based interventional devices during percutaneous transiumninal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). 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 the 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/K112957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112957: HI-Torque Powerturn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112957

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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