Cleared Traditional

EnSite Velocity Cardiac Mapping System v5.2 (K172396) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172396 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
258d
Days
Class 2
Risk

K172396 is an FDA 510(k) clearance for the EnSite Velocity Cardiac Mapping System v5.2. 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 April 23, 2018 after a review of 258 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 K172396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date April 23, 2018
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
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 164
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K172396.
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · Boston Scientific Corporation · Jul 2018
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
K173977 · Biosense Webster, Inc. · Jun 2018
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
K180238 · Biosense Webster, Inc. · Jun 2018
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · Biosense Webster, Inc. · Jul 2017
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
K163381 · Edwards Lifesciences, LLC · Apr 2017
RHYTHMIA HDx Mapping System
K162793 · Boston Scientific Corporation · Mar 2017