510(k) · Cleared
ClearedVdrive system, Vdrive Duo, Vdrive with V-Sono
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 Jun 17, 2015 as substantially equivalent to K141530 (Stereotaxis, Inc., 2014) after a 128-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jun 17, 2015
- Review
- 128 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K900765 (1990). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 6 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 5 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 4 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 3 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 2 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 1 generation backK141530 Vdrive System/ Vdrive Duo/ Vdrive with V-CasStereotaxis, Inc. · 2014
- This deviceK150312 Vdrive system, Vdrive Duo, Vdrive with V-SonoStereotaxis, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −6 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −5 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −4 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −3 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −2 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| −1 | K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-Cas | Stereotaxis, Inc. | 2014 | — |
| 0 (this device) | K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-CasSummary page 5…Code: DXX, DQX Classification Panel: Cardiovascular Predicate Devices: Vdrive® with V-CAS™, K141530 (Stereotaxis) Device Vdrive® with V-Sono™ is intended to control a compatible Intracardiac description Echocardi… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 13 ancestors have a recall of any class.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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, Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used…
Read the full statement (416 words)
The Vdrive® system is intended to stabilize, navigate and remotely control:
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,
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, and
Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
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® 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-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150312: Vdrive system, Vdrive Duo, Vdrive with V-Sono.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150312
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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