510(k) · Cleared
ClearedHI-Torque Balance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular · DQX Wire, Guide, Catheter
Cleared on Oct 21, 2015 as substantially equivalent to K925381 (Advanced Cardiovascular Systems, Inc., 1993) and 10 other predicates after a 30-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 21, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 7 generations to K913353 (1991). 22 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 6 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 5 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 4 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 3 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- 2 generations backK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009
- 1 generation backK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010
- This deviceK152709 HI-Torque BalanceAbbott Vascular · 2015
- Descendant · cites it directly · 0 of its ownK182553 Inno-PathwireSuzhou Innomed Medical Device Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK173052 Heraeus TMW GuidewireHeraeus Medical Components, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −6 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −5 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −4 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −3 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| −2 | K091825 | HI-Torque Progress Guide Wire Family | Abbott Vascular, Inc. | 2009 | — |
| −1 | K101011 | HI-Torque Balance Middleweight Universal | Abbott Vascular, Inc. | 2010 | — |
| 0 (this device) | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| +1 | K182553 | Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. | 2019 | — |
| +1 | K173052 | Heraeus TMW Guidewire | Heraeus Medical Components, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (11)
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 |
|---|---|---|---|
| * | K925381 | Acs HI-Torque Balance (TM) Guide WireSummary page 10…Coronary Guide Wire 9. Device Classification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE Guide Wire (K925381, cleared February 12, 1993), HI-TORQUE BALANCE… | 1993 |
| * | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Summary page 10…d February 12, 1993), HI-TORQUE BALANCE Guide Wire with Hydrocoat Hydrophilic Coating, (K973494, cleared December 12, 1997) and HI-TORQUE BALANCE Guide… | 1997 |
| * | K021228 | HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the…Summary page 10…philic Coating, (K973494, cleared December 12, 1997) and HI-TORQUE BALANCE Guide Wire, (K021228, cleared May 15, 2002) 11. Device and Change Description The HI-TORQUE BALANCE Guide Wires are available in a 0.014" outer diam… | 2002 |
| * | K991152 | HI-Torque Balance Trek Guide WireSummary page 12…lassification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE TREK Guide Wire (K991152, cleared April 29, 1999) and HI- TORQUE BALANCE TREK Guide Wire,… | 1999 |
| * | K982083 | Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic CoatingSummary page 14…HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire with Hydrocoat Hydrophilic Coating (K982083, cleared September 11, 1998) and HI- TORQUE BALANCE HEAVYWEIGHT Guide… | 1998 |
| * | K971815 | Asc Balance Middleweight Guide WireSummary page 16…on Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire (K971815, cleared July 9, 1997), HI- TORQUE BALANCE MIDDLEWEIGHT Guide… | 1997 |
| * | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…Summary page 18…HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire with Hydrocoat Hydrophilic Coating (K013833, cleared January 16, 2002), HI-TORQUE BALANCE MIDDL… | 2002 |
| * | K031678 | HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic CoatingSummary page 18…2), HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire with Hydrocoat Hydrophilic Coating (K031678, cleared August 26, 2003) and HI-TORQUE BALANCE MID… | 2003 |
| * | K101011 | HI-Torque Balance Middleweight UniversalSummary page 18…cleared August 26, 2003) and HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire, (K101011, cleared May 24, 2010) 11. Device Description The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire is a steerable guide wire… | 2010 |
| * | K072460 | HI-Torque Balance Middleweight Universal II Guide WireSummary page 20…Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide (K072460, cleared April 4, 2008). 11. Device Description The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVE… | 2008 |
| * | K103101 | HI-Torque Balance Middleweight EliteSummary page 22…tion Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide (K103101, cleared February 10, 2011). 11. Device Description The HI-TORQUE BALANCE MIDDLEWEIGHT… | 2011 |
What descends from it? (2)
2 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 24 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K182553 (Suzhou Innomed Medical Device Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K925381.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty…
Read the full statement (161 words)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
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.
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/K152709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152709: HI-Torque Balance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152709
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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