Cleared Special

K083328 - ENSITE SYSTEM

K083328 is the FDA 510(k) clearance for ENSITE SYSTEM by St Jude Medical. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Special 510(k) pathway after a 191-day FDA review.

K083328 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
191d
Days
Class 2
Risk

K083328 is an FDA 510(k) clearance for the ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by St Jude Medical (St. Paul, US). The FDA issued a Cleared decision on May 22, 2009 after a review of 191 days - an extended review 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. 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 St Jude Medical devices

Submission Details

510(k) Number K083328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date May 22, 2009
Days to Decision 191 days
Submission Type Special
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
66d slower than avg
Panel avg: 125d · This submission: 191d
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 259
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