510(k) · Cleared
ClearedHi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DQX Wire, Guide, Catheter
Cleared on Jul 25, 2025 as substantially equivalent to K240997 (Abbott Medical, 2024) after a 150-day review. Its family tree reaches back 9 generations to 1991. 2 of the 25 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 25, 2025
- Review
- 150 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913353 (1991). 24 ancestors in all. No later device cites it as a predicate yet. 2 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 5 generations between
- 3 generations backK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
- 2 generations backK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
- 1 generation backK240997 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2024
- This deviceK250552 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2025
Show all 9 generations
- Root · 9 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 8 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 7 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 6 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 5 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- 4 generations backK103101 HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
- 3 generations backK112957 HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
- 2 generations backK122573 HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc. · 2012
- 1 generation backK240997 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2024
- This deviceK250552 Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide…Abbott Medical · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −8 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −7 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −6 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −5 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| −4 | K103101 | HI-Torque Balance Middleweight Elite | Abbott Vascular-Cardiac Therapies | 2011 | — |
| −3 | K112957 | HI-Torque Powerturn | Abbott Vascular-Cardiac Therapies | 2011 | — |
| −2 | K122573 | HI-Torque Command Guide Wire Family | Abbott Vascular, Inc. | 2012 | — |
| −1 | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | Abbott Medical | 2024 | — |
| 0 (this device) | K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | Abbott Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 1 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireSummary page 5…Wire, Guide, Catheter Product Classification Class II Product Code DQX Product Regulation 21 CFR 870.1330 Number Predicate Device K240997: Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire Device Description Th… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular · 2009 · 4 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 24 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.
The guide wires may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250552: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250552
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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