510(k) · Cleared

Cleared

HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the Balance Middleweight Universal Guide

K021228510(k) SpecialCleared May 15, 200227-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 15, 2002 after a 27-day review. The FDA summary names no predicate by number. 22 later devices descend from it.

Decided: May 15, 2002
Review: 27 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

22 later devices descend from it, 3 citing it directly.

This deviceK021228 HI-Torque Balance, Balance Middleweight, Balance Heavyweight…Guidant Corp. · 2002
Descendant · cites it directly · 11 of its ownK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
Descendant · 2 generations on · 6 of its ownK143587 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT…Boston Scientific Corporation · 2015 · Recalled
Descendant · cites it directly · 6 of its ownK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
Descendant · 2 generations on · 4 of its ownK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
Descendant · 3 generations on · 3 of its ownK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2003high 4 (2015) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all

K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · cites it directly11descendants
K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation · 2015 · 2 generations on6descendants
K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · cites it directly6descendants
K032183IQ Hydrophilic Guide WireBoston Scientific Corp · 2003 · 2 generations on4descendants
K040140IQ Guide WireBoston Scientific Corp · 2004 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021228	HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and…	Guidant Corp.	2002	—
+1	K030617	PT2 Guide Wire and Addwire Extension Wire	Boston Scientific Scimed, Inc.	2003	4
+2	K143587	ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire…	Boston Scientific Corporation	2015	1
+1	K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	—
+2	K032183	IQ Hydrophilic Guide Wire	Boston Scientific Corp	2003	—
+3	K040140	IQ Guide Wire	Boston Scientific Corp	2004	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	1	0
2008	1	0
2012	1	0
2014	1	0
2015	4	0
2016	1	0
2017	3	0
2018	2	0
2019	3	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K021228, 2002–2025Source: 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?

The FDA summary names no predicate by number.

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K030617	PT2 Guide Wire and Addwire Extension Wire	Boston Scientific Scimed, Inc.	2003	11
K122573	HI-Torque Command Guide Wire Family	Abbott Vascular, Inc.	2012	6
K152709	HI-Torque Balance	Abbott Vascular	2015	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?

Of its descendants, K030617 (Boston Scientific Scimed, Inc., 2003) has gone furthest, with 11 descendants of its own.

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) and 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/K021228 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021228: HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the Balance Middleweight Universal Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021228

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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