Cleared Special

K120301 - MEDIGUIDE TECHNOLOGY

K120301 is an FDA 510(k) clearance for MEDIGUIDE TECHNOLOGY, manufactured by St. Jude Medical, Mediguide Navigation Systems. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 24-day FDA review.

K120301 · St. Jude Medical, Mediguide Navigation Systems · Cardiovascular device
Download Printable Device Report (PDF)
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Feb 2012
Decision
24d
Days
Class 2
Risk

K120301 is an FDA 510(k) clearance for the MEDIGUIDE TECHNOLOGY. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by St. Jude Medical, Mediguide Navigation Systems (Washington, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St. Jude Medical, Mediguide Navigation Systems devices

FDA 510(k) Submission Details - K120301

510(k) Number K120301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date February 24, 2012
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

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 295
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K120301.
ST80I STRESS TEST SYSTEM
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K111200 · Ge Healthcare · Oct 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
K112007 · Biosense Webster, Inc. · Oct 2011