510(k) · Cleared
ClearedTorque Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 15, 1994 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 15, 1994
- Review
- 88 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK936032 Torque DeviceMerit Medical Systems, Inc. · 1994
- Descendant · cites it directly · 3 of its ownK141054 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 · 1 of its ownK964352 Torque DeviceB.Braun Medical, Inc. · 1997
- Descendant · 2 generations on · 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141054Distal Access Torque DeviceDistal Access, LLC · 2014 · cites it directly3descendants
- K170684Firebow Wire Torque Assist DeviceVesatek, LLC · 2017 · cites it directly1descendant
- K964352Torque DeviceB.Braun Medical, Inc. · 1997 · cites it directly1descendant
- K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022 · 2 generations on0descendants
- K200120LiteSaber Wire Torque Assist DeviceVesatek, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936032 | Torque Device | Merit Medical Systems, Inc. | 1994 | — |
| +1 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| +1 | K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | 2017 | — |
| +1 | K964352 | Torque Device | B.Braun Medical, Inc. | 1997 | — |
| +2 | K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | 2022 | — |
| +2 | K200120 | LiteSaber Wire Torque Assist Device | Vesatek, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K141054 (Distal Access, LLC, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K936032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K936032: Torque Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K936032
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026