510(k) · Cleared
ClearedHI-Torque Balance Middleweight Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular, Inc. · DQX Wire, Guide, Catheter
Cleared on May 24, 2010 as substantially equivalent to K013833 (Guidant Corp., 2002) and 2 other predicates after a 42-day review. Its family tree reaches back 6 generations to 1991. 1 of the 18 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- May 24, 2010
- Review
- 42 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913353 (1991). 13 ancestors in all. 4 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- 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 backK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009
- This deviceK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK152709 HI-Torque BalanceAbbott Vascular · 2015
- Descendant · 2 generations on · 0 of its ownK182553 Inno-PathwireSuzhou Innomed Medical Device Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK173052 Heraeus TMW GuidewireHeraeus Medical Components, LLC · 2017
- Descendant · cites it directly · 0 of its ownK121398 Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · Recalled (Class I)
Class I recalls in this family
- K121398 Charlie Guidewire (Regular), Charlie Guidewire…cites it directly · 2012
Most influential descendants
Showing 4 of 4 · See all- K152709HI-Torque BalanceAbbott Vascular · 2015 · cites it directly2descendants
- K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd. · 2019 · 2 generations on0descendants
- K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC · 2017 · 2 generations on0descendants
- K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · cites it directly0descendants
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 | K091825 | HI-Torque Progress Guide Wire Family | Abbott Vascular, Inc. | 2009 | — |
| 0 (this device) | K101011 | HI-Torque Balance Middleweight Universal | Abbott Vascular, Inc. | 2010 | — |
| +1 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| +2 | K182553 | Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. | 2019 | — |
| +2 | K173052 | Heraeus TMW Guidewire | Heraeus Medical Components, LLC | 2017 | — |
| +1 | K121398 | Charlie Guidewire (Regular), Charlie Guidewire (Stiff) | Guidepath Medical, Inc. | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
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.
1 device in this family has 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
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 | Decided |
|---|---|---|---|
| * | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…Summary page 1…ame Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire (K013 83 3, cleared January 16, 2002), HI-TORQUE BALANCE MIDDL… | 2002 |
| * | K072460 | HI-Torque Balance Middleweight Universal II Guide WireSummary page 1…January 16, 2002), HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, (K(072460, cleared April 11, 2008), HT PROGRESS Guide Wire (K091 825, cleared… | 2008 |
| * | K091825 | HI-Torque Progress Guide Wire FamilySummary page 1…WEIGHT UNIVERSAL II Guide Wire, (K(072460, cleared April 11, 2008), HT PROGRESS Guide Wire (K091 825, cleared Sept. 25, 2009) 11. Device Description The HI-TORQUE BALANCE MIDDLEWEIGH'Vm UNI… | 2009 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K152709 (Abbott Vascular, 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K013833.
How does its category compare?
All DQX devicesDQX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 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 translurninal 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/K101011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101011: HI-Torque Balance Middleweight Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101011
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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