Cleared Abbreviated

K162956 - NOWCARDIO SYSTEM

K162956 is an FDA 510(k) clearance for NOWCARDIO SYSTEM, manufactured by Contex International Technologies (Canada), Inc.. The device is a Class 2 Cardiovascular device with product code QYX cleared through the Abbreviated 510(k) pathway after a 333-day FDA review.

K162956 · Contex International Technologies (Canada), Inc. · Cardiovascular device
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Sep 2017
Decision
333d
Days
Class 2
Risk

K162956 is an FDA 510(k) clearance for the NOWCARDIO SYSTEM. Classified as Outpatient Cardiac Telemetry (product code QYX), Class II - Special Controls.

Submitted by Contex International Technologies (Canada), Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 22, 2017 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Contex International Technologies (Canada), Inc. devices

FDA 510(k) Submission Details - K162956

510(k) Number K162956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date September 22, 2017
Days to Decision 333 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 125d · This submission: 333d
Pathway characteristics
Standards-based clearance path.

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.