510(k) · Cleared
ClearedHI-Torque Progress Guide Wire Family
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 Sep 25, 2009 as substantially equivalent to K030549 (Guidcorp, 2003) and 2 other predicates after a 98-day review. Its family tree reaches back 5 generations to 1991. 1 of the 22 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Sep 25, 2009
- Review
- 98 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913353 (1991). 12 ancestors in all. 9 later devices descend from it, 3 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- 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 deviceK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK152709 HI-Torque BalanceAbbott Vascular · 2015
- 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 ownK193126 HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular · 2019
- Descendant · 3 generations on · 0 of its ownK201834 HI-TORQUE PROCEED Guide Wire FamilyAbbott Vascular · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K121398 Charlie Guidewire (Regular), Charlie Guidewire…2 generations on · 2012
Most influential descendants
Showing 5 of 9 · See all- K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010 · cites it directly4descendants
- K152709HI-Torque BalanceAbbott Vascular · 2015 · 2 generations on2descendants
- K123067Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc. · 2013 · cites it directly2descendants
- K193126HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular · 2019 · 2 generations on1descendant
- K201834HI-TORQUE PROCEED Guide Wire FamilyAbbott Vascular · 2020 · 3 generations on0descendants
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) | K091825 | HI-Torque Progress Guide Wire Family | Abbott Vascular, Inc. | 2009 | — |
| +1 | K101011 | HI-Torque Balance Middleweight Universal | Abbott Vascular, Inc. | 2010 | — |
| +2 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| +1 | K123067 | Progress Guide Wire Family, Pilot Guide Wire Family | Abbott Vascular, Inc. | 2013 | — |
| +2 | K193126 | HI-TORQUE InfilTrac Guide Wire Family | Abbott Vascular | 2019 | — |
| +3 | K201834 | HI-TORQUE PROCEED Guide Wire Family | Abbott Vascular | 2020 | — |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K030549 | HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150…Summary page 1…mmon Name Guide Wire 9. Device Classification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE PILOT Guide Wire (K030549, cleared May 14, 2003), HI-TORQUE ADVANCE Guide Wir… | 2003 |
| * | K060449 | HI-Torque Advance and Advance Lite Guide WireSummary page 1…HI-TORQUE PILOT Guide Wire (K030549, cleared May 14, 2003), HI-TORQUE ADVANCE Guide Wire (K060449, cleared May30, 2006), HI- TORQUE BALANCE MIDDLEWEIGHT… | 2006 |
| * | K072460 | HI-Torque Balance Middleweight Universal II Guide WireSummary page 1…e (K060449, cleared May30, 2006), HI- TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, (K072460, cleared April 11, 2008) and Asahi guide wire families. 1 1. Device Description The HI-T… | 2008 |
| * | — | Asahi guide wire families Named without a submission number |
What descends from it? (9)
3 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 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K101011 (Abbott Vascular, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K030549.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 HI-TORQUE 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/K091825 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091825: HI-Torque Progress Guide Wire Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091825
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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