Cleared Traditional

MediGuide Technology System (K162643) - FDA 510(k) Clearance

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

K162643 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
82d
Days
Class 2
Risk

K162643 is an FDA 510(k) clearance for the MediGuide Technology 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 December 13, 2016 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St Jude Medical devices

Submission Details

510(k) Number K162643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2016
Decision Date December 13, 2016
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
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 165
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K162643.
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
iLab Polaris Multi-Modality Guidance System
K151613 · Boston Scientific Corporation · Oct 2015
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · Boston Scientific Corp · Jun 2014
INFINITY MEGACARE
K031970 · Siemens Medical Solutions USA, Inc. · Sep 2003