510(k) · Cleared
ClearedCrossTorq 14 Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientia Cardio Access, LLC · DQX Wire, Guide, Catheter
Cleared on Dec 13, 2019 as substantially equivalent to K081021 (Boston Scientific Corp, 2008) and 1 other predicate after a 24-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Dec 13, 2019
- Review
- 24 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913353 (1991). 26 ancestors in all. No later device cites it as a predicate yet.
- 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 backK030617 PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. · 2003 · Recalled
- 3 generations backK032183 IQ Hydrophilic Guide WireBoston Scientific Corp · 2003
- 2 generations backK040140 IQ Guide WireBoston Scientific Corp · 2004 · Recalled
- 1 generation backK081021 Kinetix Guidewire, Plus GuidewireBoston Scientific Corp · 2008
- This deviceK193194 CrossTorq 14 GuidewireScientia Cardio Access, LLC · 2019
View 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 | K030617 | PT2 Guide Wire and Addwire Extension Wire | Boston Scientific Scimed, Inc. | 2003 | 4 |
| −3 | K032183 | IQ Hydrophilic Guide Wire | Boston Scientific Corp | 2003 | — |
| −2 | K040140 | IQ Guide Wire | Boston Scientific Corp | 2004 | 1 |
| −1 | K081021 | Kinetix Guidewire, Plus Guidewire | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K193194 | CrossTorq 14 Guidewire | Scientia Cardio Access, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K081021 | Kinetix Guidewire, Plus GuidewireSummary page 5…s LC Tel: 801.573.2651 Fax: 801.328.2399 E-mail: [email protected] CrossTorq™ 14 Guidewire Guidewire Catheter Guide Wire per 21 CFR 870.1330 DQX Kinetix ™ Guidewire (K081021) Hornet™ Guidewire, Hornet™ 10 Guidewire, and Hornet™ 14 Guidewire (K152231) Aristotle 14 Guidewire (K173235) Aristotle 18 Guid… | 2008 |
| * | K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireSummary page 5…™ 14 Guidewire Guidewire Catheter Guide Wire per 21 CFR 870.1330 DQX Kinetix ™ Guidewire (K081021) Hornet™ Guidewire, Hornet™ 10 Guidewire, and Hornet™ 14 Guidewire (K152231) Aristotle 14 Guidewire (K173235) Aristotle 18 Guidewire (K183608) Pg. 1 Scientia Cardio Access LLC… | 2016 |
| † | K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support… | 2018 |
| † | K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard… | 2019 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 26 ancestors have a recall of any class.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193194: CrossTorq 14 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193194
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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