Cleared Traditional

K150312 - Vdrive system, Vdrive Duo, Vdrive with V-Sono

K150312 is an FDA 510(k) clearance for Vdrive system, manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K150312 · Stereotaxis, Inc. · Cardiovascular device
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Jun 2015
Decision
128d
Days
Class 2
Risk

K150312 is an FDA 510(k) clearance for the Vdrive system, Vdrive Duo, Vdrive with V-Sono. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 17, 2015 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Stereotaxis, Inc. devices

FDA 510(k) Submission Details - K150312

510(k) Number K150312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2015
Decision Date June 17, 2015
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Safis Solutions, LLC
DIANE HORWITZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXX System, Catheter Control, Steerable

All 26
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K150312.
CorPath 200 System
K150892 · Corindus, Inc. · Oct 2015
Magellan Robotic System
K151730 · Hansen Medical, Inc. · Jul 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227 · Hansen Medical, Inc. · Jul 2015
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · Stereotaxis, Inc. · Dec 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · Stereotaxis, Inc. · Sep 2014
MAGELLAN ROBOTIC SYSTEM
K141614 · Hansen Medical · Aug 2014