510(k) · Cleared
ClearedVdrive with V-Sono
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DQX Wire, Guide, Catheter
Cleared on Feb 6, 2014 as substantially equivalent to K122659 (Stereotaxis, Inc., 2013) after a 92-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Feb 6, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071029 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK071029 Cardiodrive Catheter Advancement System (Cas)Stereotaxis, Inc. · 2007
- 1 generation backK122659 Vdrive W/V-SonoStereotaxis, Inc. · 2013
- This deviceK133396 Vdrive with V-SonoStereotaxis, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK141530 Vdrive System/ Vdrive Duo/ Vdrive with V-CasStereotaxis, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK150312 Vdrive system, Vdrive Duo, Vdrive with V-SonoStereotaxis, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071029 | Cardiodrive Catheter Advancement System (Cas) | Stereotaxis, Inc. | 2007 | — |
| −1 | K122659 | Vdrive W/V-Sono | Stereotaxis, Inc. | 2013 | — |
| 0 (this device) | K133396 | Vdrive with V-Sono | Stereotaxis, Inc. | 2014 | — |
| +1 | K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-Cas | Stereotaxis, Inc. | 2014 | — |
| +2 | K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K122659 | Vdrive W/V-SonoSummary page 1…lassification Panel: Cardiovascular Currently Marketed Substantially Equivalent Device: Vdriverm with V-SonoTM (K122659) Device The VdriveTm with V-SonoTm is comprised of three major components, description 1. VdriV… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-Cas | 2014 | 1 |
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 7 years and passes through 1 company; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141530 (Stereotaxis, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122659.
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?
The VdriveTrM System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-SonoTM disposable sets in the VdriveTM system. Compatible catheters include Biosense Webster, Inc. SoundstarTM 3D Ultrasound Catheters and Acuson AcuNavTM Ultrasound Catheters. Other…
Read the full statement (93 words)
The VdriveTrM System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-SonoTM disposable sets in the VdriveTM system. Compatible catheters include Biosense Webster, Inc. SoundstarTM 3D Ultrasound Catheters and Acuson AcuNavTM Ultrasound Catheters. Other models of ICE catheters have not been tested with the VdriveM system.
VdriveTM with V-SonoTM is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133396 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133396: Vdrive with V-Sono.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133396
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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