Cleared Special

K112688 - ENSITE VELOCITY SYSTEM V.3.0

K112688 is the FDA 510(k) clearance for ENSITE VELOCITY SYSTEM V.3.0 by St Jude Medical. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Special 510(k) pathway after a 55-day FDA review.

K112688 · St Jude Medical · Cardiovascular device
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Nov 2011
Decision
55d
Days
Class 2
Risk

K112688 is an FDA 510(k) clearance for the ENSITE VELOCITY SYSTEM V.3.0. 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 November 9, 2011 after a review of 55 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 devices

Submission Details

510(k) Number K112688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2011
Decision Date November 09, 2011
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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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