Cleared Special

K113372 - NUVANT, MOBILC CARDIAC TELEMETRY

K113372 is an FDA 510(k) clearance for NUVANT, manufactured by Corventis, Inc.. The device is a Class 2 Cardiovascular device with product code QYX cleared through the Special 510(k) pathway after a 112-day FDA review.

K113372 · Corventis, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
112d
Days
Class 2
Risk

K113372 is an FDA 510(k) clearance for the NUVANT, MOBILC CARDIAC TELEMETRY. Classified as Outpatient Cardiac Telemetry (product code QYX), Class II - Special Controls.

Submitted by Corventis, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 7, 2012 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113372

510(k) Number K113372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date March 07, 2012
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

QYX Device Classification - Class 2, Special Controls

Product Code QYX Outpatient Cardiac Telemetry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
Definition Devices Are Intended To Continuously Record And Analyze Electrocardiograms For Automatic Detection And Recording Of Cardiac Electrical Activity In An Outpatient Setting. Detected, Notifiable Events Are Transmitted To The Prescribing Clinician During The Monitoring Period By A 24/7 Attended Analysis Center After Review By A Qualified Individual. Devices May Allow Remote Access And Display Of Electrocardiograms Acquired. Not For Use For Detection Or Notification Of Hemodynamically Unstable Or Life-threatening Arrhythmias Or Cardiac Events Requiring Urgent Medical Response. Not Intended For Patients At Elevated Risk Of Serious Cardiovascular Events That Would Require Prompt Intervention. It Is Not Intended For Monitoring Patients During Cardiac Rehabilitation Outside Of Healthcare Facilities. Devices Are Intended For Prescription Use Only.
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 - QYX Outpatient Cardiac Telemetry

All 20
Devices cleared under the same product code (QYX) and FDA review panel - the closest regulatory comparables to K113372.
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
K160064 · Infobionic, Inc. · Mar 2016
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
K133753 · Infobionic, Inc. · Sep 2014
NUVANT MCT SYSTEM
K133701 · Corventis, Inc. · Feb 2014
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
K103706 · Applied Cardiac Systems, Inc. · Aug 2011
NUVANT, MOBILE CARDIAC TELEMETRY
K111917 · Corventis, Inc. · Aug 2011
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
K093288 · Cardionet, Inc. · Apr 2010
K113372 · NUVANT, MOBILC CARDIAC TELEMETRY
Download PDF FDA Summary Corventis, Inc.