510(k) · Cleared
ClearedMerit Medical Systems, Inc., Guide Wire Torque 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 Dec 14, 2007 as substantially equivalent to K040498 (Sedat S.A., 2004) after a 95-day review. Its family tree reaches back 3 generations to 1985. 3 later devices descend from it.
- Decided
- Dec 14, 2007
- Review
- 95 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K854261 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 2 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 1 generation backK040498 MyshellSedat S.A. · 2004
- This deviceK072552 Merit Medical Systems, Inc., Guide Wire Torque DeviceMerit Medical Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK112674 Navis TorquerNavis Medical,Inc · 2012
- Descendant · cites it directly · 0 of its ownK100425 Haskal Torque DeviceElcam Medical Acal · 2010
- Descendant · cites it directly · 0 of its ownK093822 Docking Station,Teirstein Edge,Angioassist Combination Device…Shepherd Scientific, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K112674Navis TorquerNavis Medical,Inc · 2012 · cites it directly0descendants
- K100425Haskal Torque DeviceElcam Medical Acal · 2010 · cites it directly0descendants
- K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist FamilyShepherd Scientific, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −2 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −1 | K040498 | Myshell | Sedat S.A. | 2004 | — |
| 0 (this device) | K072552 | Merit Medical Systems, Inc., Guide Wire Torque Device | Merit Medical Systems, Inc. | 2007 | — |
| +1 | K112674 | Navis Torquer | Navis Medical,Inc | 2012 | — |
| +1 | K100425 | Haskal Torque Device | Elcam Medical Acal | 2010 | — |
| +1 | K093822 | Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist… | Shepherd Scientific, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K040498 | MyshellSummary page 1…Guide Wire Torque Device CLASSIFICATION NAME: Wire, Guide, Catheter, 870.1330 PREDICATE DEVICES: MYSHELL, Alligatork Torque Device, K040498 DEVICE DESCRIPTION: The Guide Wire Torque Device is a guide wire accessory developed to assist in the manipulation and placeme… | 2004 |
What descends from it? (3)
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K112674 (Navis Medical,Inc, 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K040498.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072552 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072552: Merit Medical Systems, Inc., Guide Wire Torque Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072552
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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