Cleared Traditional

K072371 - ODYSSEY WORKSTATION

K072371 is an FDA 510(k) clearance for ODYSSEY WORKSTATION, 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 83-day FDA review.

K072371 · Stereotaxis, Inc. · Cardiovascular device
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Nov 2007
Decision
83d
Days
Class 2
Risk

K072371 is an FDA 510(k) clearance for the ODYSSEY WORKSTATION. 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 November 14, 2007 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stereotaxis, Inc. devices

FDA 510(k) Submission Details - K072371

510(k) Number K072371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2007
Decision Date November 14, 2007
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 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 K072371.
CORPATH 200 SYSTEM
K120834 · Corindus, Inc. · Jul 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · Catheter Robotics, Inc. · Jun 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · Hansen Medical, Inc. · May 2012
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
K051760 · Stereotaxis, Inc. · May 2006
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
K032937 · Stereotaxis, Inc. · Jul 2004
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555 · Stereotaxis, Inc. · Jan 2003