Cleared Special

K093092 - ODYSSEY WORKSTATION

K093092 is the FDA 510(k) clearance for ODYSSEY WORKSTATION by Stereotaxis, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Special 510(k) pathway after a 112-day FDA review.

K093092 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
112d
Days
Class 2
Risk

K093092 is an FDA 510(k) clearance for the ODYSSEY WORKSTATION. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 21, 2010 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stereotaxis, Inc. devices

Submission Details

510(k) Number K093092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date January 21, 2010
Days to Decision 112 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 247
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K093092.
CARTO XP EP NAVIGATION SYSTEM, VERSION 10
K093566 · Biosense Webster, Inc. · Jun 2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
K101419 · St Jude Medical · Jun 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · St Jude Medical · Feb 2010
MARS HOLTER ANALYSIS WORKSTATION
K093141 · Ge Medical Systems Information Technologies · Dec 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · St Jude Medical · Dec 2009
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
K093455 · Biosense Webster, Inc. · Dec 2009