510(k) · Cleared

Cleared

HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide Wire with

K101116510(k) SpecialCleared Jun 23, 201063-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 Jun 23, 2010 as substantially equivalent to K030549 (Guidcorp, 2003) after a 63-day review. Its family tree reaches back 4 generations to 2000. 10 later devices descend from it.

Decided: Jun 23, 2010
Review: 63 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K002206 (2000). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
3 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
2 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
1 generation backK030549 HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating…Guidcorp · 2003
This deviceK101116 HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic…Abbott Vascular-Cardiac Therapies · 2010
Descendant · cites it directly · 6 of its ownK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
Descendant · cites it directly · 2 of its ownK123067 Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc. · 2013
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 ownK193126 HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular · 2019
Descendant · 2 generations on · 1 of its ownK152404 Hi-Torque Command 18 Guide WireAbbott Vascular · 2015

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012high 2 (2019) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all

K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · cites it directly6descendants
K123067Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc. · 2013 · cites it directly2descendants
K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2024 · 2 generations on1descendant
K193126HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular · 2019 · 2 generations on1descendant
K152404Hi-Torque Command 18 Guide WireAbbott Vascular · 2015 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K002206	HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…	Guidant Corp.	2000	—
−3	K013092	HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating	Guidant Corp.	2001	—
−2	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	—
0 (this device)	K101116	HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating…	Abbott Vascular-Cardiac Therapies	2010	—
+1	K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	—
+1	K123067	Progress Guide Wire Family, Pilot Guide Wire Family	Abbott Vascular, Inc.	2013	—
+2	K240997	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire	Abbott Medical	2024	—
+2	K193126	HI-TORQUE InfilTrac Guide Wire Family	Abbott Vascular	2019	—
+2	K152404	Hi-Torque Command 18 Guide Wire	Abbott Vascular	2015	—

Descendants by year cleared

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

FIG. 1 — Lineage of K101116, 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.

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
*	K030549	HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150… Summary page 1 …Guide Wire 9. Device Classification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE PILOT Guide Wire (K030549, cleared May 14, 2003) 11. Device Description The HI-TORQUE PJLOT'Um Guide Wire with…	Guidcorp	2003	—

Also cleared against K030549: 2 other devices →

What descends from it? (10)

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
K123067	Progress Guide Wire Family, Pilot Guide Wire Family	Abbott Vascular, Inc.	2013	2

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 10 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K122573 (Abbott Vascular, Inc., 2012) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K030549.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101116: HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide Wire with.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101116

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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