Cleared Traditional

K130727 - ENSITE VELOCITY SYSTEM

K130727 is an FDA 510(k) clearance for ENSITE VELOCITY SYSTEM, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K130727 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
164d
Days
Class 2
Risk

K130727 is an FDA 510(k) clearance for the ENSITE VELOCITY SYSTEM. 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 August 29, 2013 after a review of 164 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all St Jude Medical devices

FDA 510(k) Submission Details - K130727

510(k) Number K130727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date August 29, 2013
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 373
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K130727.
RHYTHM VIEW WORKSTATION
K133305 · Topera, Inc. · Dec 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · Ge Medical Systems Information Technologies, Inc. · Dec 2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · St Jude Medical · Sep 2013
CARDIODAY
K130516 · Getemed Medizin- Und Informationstechnik AG · Aug 2013
SENSIS, SENSIS LITE
K131812 · Siemens Medi Cal Solutions, Inc. · Jul 2013
RHYTHMIA MAPPING SYSTEM
K130750 · Rhythmia Medical, Inc. · Jul 2013