510(k) · Cleared
ClearedVdrive with V-Loop/ Vdrive Duo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DXX System, Catheter Control, Steerable
Cleared on Sep 3, 2014 as substantially equivalent to K122659 (Stereotaxis, Inc., 2013) after a 156-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Sep 3, 2014
- Review
- 156 days
- Class
- Class II
- Product code
- DXX
- 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 deviceK140804 Vdrive with V-Loop/ Vdrive DuoStereotaxis, 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) | K140804 | Vdrive with V-Loop/ Vdrive Duo | 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 DXX? 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 DXX device
- #1 K251792 Stereotaxis GenesisX RMN with Navigant ™…score 13.9 · 3 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 5…tion Panel: Cardiovascular Currently Marketed Substantially Equivalent Device: Vdrive™ with V-Sono™ (K122659) Device The Vdrive™ with V-Loop™ is provides a remote method of controlling the description advanc… | 2013 |
| † | K133396 | Vdrive with V-Sono | 2014 |
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 DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DXX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXX
76in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXX
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXX
1in 2024
MAUDE reports naming product code DXX, 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 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 4 | 155 | 0 | 2 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 4 | 104 | 1 | 14 |
| 2015 | 4 | 156 | 0 | 2 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 3 | 76 | 0 | 9 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Vdrive™ system is intended to stabilize, navigate and remotely control: • compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive™ system. • compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when…
Read the full statement (247 words)
The Vdrive™ system is intended to stabilize, navigate and remotely control:
• compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive™ system.
• compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive™ system.
The Vdrive™ with V-Loop™ disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive™ system.
The Vdrive™ with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140804 · printed Nov 3, 2026
Cite this page
510(k) Report. “K140804: Vdrive with V-Loop/ Vdrive Duo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140804
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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