Cleared Traditional

VDRIVE WITH V-LOOP/ VDRIVE DUO (K140804) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140804 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
156d
Days
Class 2
Risk

K140804 is an FDA 510(k) clearance for the VDRIVE WITH V-LOOP/ VDRIVE DUO. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Fairfax, US). The FDA issued a Cleared decision on September 3, 2014 after a review of 156 days - an extended review cycle.

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

Submission Details

510(k) Number K140804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date September 03, 2014
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - DXX System, Catheter Control, Steerable

All 32
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K140804.
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
K251792 · Stereotaxis, Inc. · Nov 2025
LIBERTY Endovascular Robotic System (LIBERTYOS)
K243789 · Microbot Medical , Ltd. · Sep 2025
CorPath GRX System
K221464 · Corindus, Inc. · Jul 2022
CorPath GRX System
K202275 · Corindus, Inc. · Dec 2020
CorPath GRX System
K180517 · Corindus, Inc. · Mar 2018
CorPath GRX System
K173806 · Corindus, Inc. · Mar 2018