510(k) · Cleared
ClearedVsi Torque Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQX Wire, Guide, Catheter
Cleared on Apr 30, 2010 as substantially equivalent to K032411 (Js Vascular, Inc., 2003) and 2 other predicates after a 107-day review. Its family tree reaches back 6 generations to 1985. 1 of the 19 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 107 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K854261 (1985). 14 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 5 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 4 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- 3 generations backK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- 2 generations backK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- 1 generation backK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
- This deviceK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK170684 Firebow Wire Torque Assist DeviceVesatek, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK221917 Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK200120 LiteSaber Wire Torque Assist DeviceVesatek, LLC · 2020
Class I recalls in this family
- K092711 Guardian II Hemostasis Valvedirect predicate · 2009
Most influential descendants
Showing 4 of 4 · See all- K141054Distal Access Torque DeviceDistal Access, LLC · 2014 · cites it directly3descendants
- K170684Firebow Wire Torque Assist DeviceVesatek, LLC · 2017 · 2 generations on1descendant
- K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022 · 2 generations on0descendants
- K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −5 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −4 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| −3 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| −2 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| −1 | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | Class I |
| 0 (this device) | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| +1 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| +2 | K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | 2017 | — |
| +2 | K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | 2022 | — |
| +3 | K200120 | LiteSaber Wire Torque Assist Device | Vesatek, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K032411 | JS Vascular Guide Wire Vise/Torque Device | 2003 |
| * | K021243 | Ilt Torquer, Model 114TR1Summary page 1…fication Name 870.1330 Wire, Guide, Catheter; Class 11 Predicate Devices K03241 I Wire Vise (IS Vascular, Inc.) K02 1243 ILT Torquer (IntraLuminal Therapeutics, Inc.) K09271 I Guidewire Torquer (Zerusa Limited) Devi… | 2002 |
| * | K092711 | Guardian II Hemostasis Valve | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141054 | Distal Access Torque Device | 2014 | 3 |
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.
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141054 (Distal Access, LLC, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K032411.
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?
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100093: Vsi Torque Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100093
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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