510(k) · Cleared
ClearedHI-Torque Balance Middleweight Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular-Cardiac Therapies · DQX Wire, Guide, Catheter
Cleared on Feb 10, 2011 as substantially equivalent to K971815 (Guidant Corp., 1997) and 3 other predicates after a 113-day review. Its family tree reaches back 5 generations to 1991. 13 later devices descend from it.
- Decided
- Feb 10, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K913353 (1991). 11 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 4 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 3 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 2 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 1 generation backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- This deviceK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
- Descendant · cites it directly · 7 of its ownK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
- Descendant · cites it directly · 6 of its ownK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK152709 HI-Torque BalanceAbbott Vascular · 2015
- 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 ownK152404 Hi-Torque Command 18 Guide WireAbbott Vascular · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011 · cites it directly7descendants
- K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012 · cites it directly6descendants
- K152709HI-Torque BalanceAbbott Vascular · 2015 · cites it directly2descendants
- K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical · 2024 · 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 |
|---|---|---|---|---|---|
| −5 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −4 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −3 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −2 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −1 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| 0 (this device) | K103101 | HI-Torque Balance Middleweight Elite | Abbott Vascular-Cardiac Therapies | 2011 | — |
| +1 | K112957 | HI-Torque Powerturn | Abbott Vascular-Cardiac Therapies | 2011 | — |
| +1 | K122573 | HI-Torque Command Guide Wire Family | Abbott Vascular, Inc. | 2012 | — |
| +1 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| +2 | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | Abbott Medical | 2024 | — |
| +2 | K152404 | Hi-Torque Command 18 Guide Wire | Abbott Vascular | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K971815 | Asc Balance Middleweight Guide WireSummary page 1…assification Name Catheter Guide Wire (DQX) 10. Predicate Device Name BALANCE MIDDLEWEIGHT'(BMW) Guide Wire (K971815, cleared July 9, 1997 and K973494, cleared December 12, 1997), HI-… | 1997 |
| * | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Summary page 1…Name BALANCE MIDDLEWEIGHT'(BMW) Guide Wire (K971815, cleared July 9, 1997 and K973494, cleared December 12, 1997), HI- TORQUE BALANCE MIDDLEWEIGHT… | 1997 |
| * | K072460 | HI-Torque Balance Middleweight Universal II Guide WireSummary page 1…73494, cleared December 12, 1997), HI- TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 11 Guide Wire (K072460, cleared April 11, 2008), and the Terumo Runthrough… | 2008 |
| * | K063695 | Runthrough NSSummary page 1…UNIVERSAL 11 Guide Wire (K072460, cleared April 11, 2008), and the Terumo Runthrough (K063695, cleared April 4, 2007) 11. Device Description The HI-TORQUE BALANCE MIDDLEWEIGHTTM ELITE Guide Wire is a steerable guide wire… | 2007 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K112957 (Abbott Vascular-Cardiac Therapies, 2011) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K971815.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
This Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103101: HI-Torque Balance Middleweight Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103101
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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