Cleared Traditional

K160187 - Ensite Velocity Cardiac Mapping System ...

K160187 is the FDA 510(k) clearance for Ensite Velocity Cardiac Mapping System ... by St Jude Medical. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K160187 · St Jude Medical · Cardiovascular device
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Oct 2016
Decision
268d
Days
Class 2
Risk

K160187 is an FDA 510(k) clearance for the Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0. 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 October 21, 2016 after a review of 268 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

Submission Details

510(k) Number K160187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date October 21, 2016
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 258
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K160187.
EnSite Precision Cardiac Mapping System v2.0
K160210 · St Jude Medical · Dec 2016
AutoMark Module
K160218 · St Jude Medical · Dec 2016
MediGuide Technology System
K162643 · St Jude Medical · Dec 2016
EnSite Velocity Surface Electrode Kit
K160186 · St Jude Medical · Oct 2016
CardioConfirm
K161465 · Mortara Instrument, Inc. · Sep 2016
Holter System
K151787 · Edan Instruments, Inc. · Jan 2016