510(k) · Cleared
ClearedDistal Access Torque Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Distal Access, LLC · DQX Wire, Guide, Catheter
Cleared on Dec 10, 2014 as substantially equivalent to K936032 (Merit Medical Systems, Inc., 1994) and 1 other predicate after a 236-day review. Its family tree reaches back 7 generations to 1985. 1 of the 20 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Dec 10, 2014
- Review
- 236 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K854261 (1985). 16 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 6 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 5 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- 4 generations backK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- 3 generations backK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- 2 generations backK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
- 1 generation backK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- This deviceK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
- Descendant · cites it directly · 1 of its ownK170684 Firebow Wire Torque Assist DeviceVesatek, LLC · 2017
- Descendant · cites it directly · 0 of its ownK221917 Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK200120 LiteSaber Wire Torque Assist DeviceVesatek, LLC · 2020
Class I recalls in this family
- K092711 Guardian II Hemostasis Valve2 generations back · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −6 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −5 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| −4 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| −3 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| −2 | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | Class I |
| −1 | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| 0 (this device) | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| +1 | K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | 2017 | — |
| +1 | K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | 2022 | — |
| +2 | 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 |
| 1994 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K936032 | Torque DeviceSummary page 4…(74DQY; 21 CFR § 870.1250) Manufacturer: Merit Medical Systems, Inc. Premarket Notification: K936032 December 17, 1993 Predicate Trade Name: VSI torque device Devices… | 1994 |
| * | K100093 | Vsi Torque DeviceSummary page 4…(74DQX; 21 CFR § 870.1330) Manufacturer: Vascular Solutions, Inc. Premarket Notification: K100093 April 30,2010 Page 1 of 4… | 2010 |
What descends from it? (3)
2 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.
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170684 (Vesatek, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K936032.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Distal Access torque devices are used to maneuver guide wires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141054: Distal Access 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/K141054
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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