510(k) · Cleared
ClearedHI-Torque Winn 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 Jul 8, 2010 as substantially equivalent to K091825 (Abbott Vascular, Inc., 2009) after a 27-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jul 8, 2010
- Review
- 27 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913353 (1991). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK101648 HI-Torque Winn Guide Wire FamilyAbbott Vascular, Inc. · 2010
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) | K101648 | HI-Torque Winn Guide Wire Family | Abbott Vascular, Inc. | 2010 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K091825 | HI-Torque Progress Guide Wire FamilySummary page 1…ame Guide Wire 9. Device Classification Name Catheter Guide Wire (DQX) 10. Predicate Device Name HI-TORQUE PROGRESS Guide Wire (K091 825, cleared September 25, 2009) I I. Device Description The Hi-Torque Winn Guide Wire Fami… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 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.
- 2 other devices also cite its predicate K091825.
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?
This Hi-Torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous translumninal 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/K101648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101648: HI-Torque Winn Guide Wire Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101648
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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