510(k) · Cleared

Cleared

HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating

K013092510(k) TraditionalCleared Dec 13, 200187-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 Dec 13, 2001 as substantially equivalent to K002206 (Guidant Corp., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 2 of the 35 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.

Decided: Dec 13, 2001
Review: 87 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002206 (2000). 33 later devices descend from it, 2 citing it directly. 2 of the 35 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
This deviceK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
Descendant · cites it directly · 32 of its ownK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
Descendant · cites it directly · 18 of its ownK030549 HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating…Guidcorp · 2003
Descendant · 2 generations on · 10 of its ownK101116 HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic…Abbott Vascular-Cardiac Therapies · 2010
Descendant · 2 generations on · 10 of its ownK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
Descendant · 2 generations on · 9 of its ownK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2002high 3 (2009) · low 0 (2005)2026

Class I recalls in this family

K063210 Attain Hybrid Guide Wires, Model GWR419378…3 generations on · 2007
K121398 Charlie Guidewire (Regular), Charlie Guidewire…4 generations on · 2012

Most influential descendants

Showing 5 of 33 · See all

K020340Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic CoatingGuidant Corp. · 2002 · cites it directly32descendants
K030549HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150…Guidcorp · 2003 · cites it directly18descendants
K101116HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…Abbott Vascular-Cardiac Therapies · 2010 · 2 generations on10descendants
K030019Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003 · 2 generations on10descendants
K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidant Corp.	2000	—
0 (this device)	K013092	HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating	Guidant Corp.	2001	—
+1	K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat…	Guidant Corp.	2002	—
+1	K030549	HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidcorp	2003	—
+2	K101116	HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating…	Abbott Vascular-Cardiac Therapies	2010	—
+2	K030019	Modification to HI-Torque Whisper Guidewire	Guidant Corp.	2003	—
+2	K091825	HI-Torque Progress Guide Wire Family	Abbott Vascular, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	2	0
2004	1	0
2006	1	0
2007	1	1
2008	1	0
2009	3	0
2010	3	0
2011	2	0
2012	3	1
2013	1	0
2014	2	0
2015	3	0
2017	2	0
2019	3	0
2020	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K013092, 2000–2025Source: 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

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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
*	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper MS… Summary page 1 …ide Wire 9. Device Classification Name: Catheter Guide Wire (74DQX) 10. Predicate Device: HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating (K002206) 11. Device Description: The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating are guide wires with a…	Guidant Corp.	2000	—

Also cleared against K002206: 3 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K020340	Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating	Guidant Corp.	2002	32
K030549	HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150…	Guidcorp	2003	18

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.

K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K020340 (Guidant Corp., 2002) has gone furthest, with 32 descendants of its own.
3 other devices also cite its predicate K002206.

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?

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular 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/K013092 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013092: HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013092

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026