510(k) · Cleared

Cleared

HI-Torque Extra S'port Guidewire

K021285510(k) TraditionalCleared May 2, 200214-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

Guidant Corp. · DQX Wire, Guide, Catheter

Cleared on May 2, 2002 as substantially equivalent to K983033 (Guidant Corp., 1998) after a 14-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.

Decided: May 2, 2002
Review: 14 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K952860 (1995). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK952860 The Niner Nitinol GuidewireMicrovena Corp. · 1995
1 generation backK983033 Acs HT Balance Middleweight Guide WireGuidant Corp. · 1998
This deviceK021285 HI-Torque Extra S'port GuidewireGuidant Corp. · 2002
Descendant · cites it directly · 1 of its ownK023300 HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS…Guidant Corp. · 2002
Descendant · cites it directly · 0 of its ownK052965 Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006
Descendant · 2 generations on · 0 of its ownK041762 Finishing Wire SupportrakGuidant Corporation · 2004

Most influential descendants

Showing 3 of 3 · See all

K023300HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS CS-J; HI-Torque Whisper…Guidant Corp. · 2002 · cites it directly1descendant
K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006 · cites it directly0descendants
K041762Finishing Wire SupportrakGuidant Corporation · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K952860	The Niner Nitinol Guidewire	Microvena Corp.	1995	—
−1	K983033	Acs HT Balance Middleweight Guide Wire	Guidant Corp.	1998	—
0 (this device)	K021285	HI-Torque Extra S'port Guidewire	Guidant Corp.	2002	—
+1	K023300	HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS CS-J…	Guidant Corp.	2002	—
+1	K052965	Easytrak 2 Stylet, Models 4826, 4829, 4832.	Guidant Corporation	2006	—
+2	K041762	Finishing Wire Supportrak	Guidant Corporation	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2006	1	0

FIG. 1 — Lineage of K021285, 1995–2006Source: 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.

Planning a device in DQX? 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
*	K983033	Acs HT Balance Middleweight Guide Wire Summary page 1 …RON MAN, Model 6725 HETORQUE WHISPER 1S, Model 6726 ' HLTORQUE WHISPER MS, Model 6737 ""“'Devnces to Which Equivalence is Claimed: HI-TORQUE BALANCED MIDDLEWEIGHT (K983033, cleared 11/10/98) with regard to intended use and all other aspects of the proposed HI-TORQUE Guide Wires are identical to the c…	Guidant Corp.	1998	—

Also cleared against K983033: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K023300	HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS CS-J; HI-Torque Whisper…	Guidant Corp.	2002	1
K052965	Easytrak 2 Stylet, Models 4826, 4829, 4832.	Guidant Corporation	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K023300 (Guidant Corp., 2002) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K983033.

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?

The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.

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/K021285 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021285: HI-Torque Extra S'port Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021285

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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