Cleared Special

K133701 - NUVANT MCT SYSTEM

K133701 is an FDA 510(k) clearance for NUVANT MCT SYSTEM, 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 65-day FDA review.

K133701 · Corventis, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
65d
Days
Class 2
Risk

K133701 is an FDA 510(k) clearance for the NUVANT MCT SYSTEM. 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 February 6, 2014 after a review of 65 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K133701

510(k) Number K133701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2013
Decision Date February 06, 2014
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 K133701.
Zio AT ECG Monitoring System
K163512 · iRhythm Technologies, Inc. · Jun 2017
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, MOBILC CARDIAC TELEMETRY
K113372 · Corventis, Inc. · Mar 2012
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
K103706 · Applied Cardiac Systems, Inc. · Aug 2011
NUVANT, MOBILE CARDIAC TELEMETRY
K111917 · Corventis, Inc. · Aug 2011
K133701 · NUVANT MCT SYSTEM
Download PDF FDA Summary Corventis, Inc.