Not Cleared Direct

DEN190047 - CADScor System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190047 · Acarix A/S · Cardiovascular device
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Nov 2020
Decision
386d
Days
Class 2
Risk

DEN190047 is an FDA 510(k) submission (not cleared) for the CADScor System. Classified as Coronary Artery Disease Risk Indicator From Acoustic Heart Signals (product code QMW), Class II - Special Controls.

Submitted by Acarix A/S (Hellerup, DK). The FDA issued a Not Cleared (DENG) decision on November 24, 2020 after a review of 386 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1420 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 386 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Acarix A/S devices

Submission Details

510(k) Number DEN190047 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 04, 2019
Decision Date November 24, 2020
Days to Decision 386 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 125d · This submission: 386d
Pathway characteristics

Device Classification

Product Code QMW Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1420
Definition A Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals Is A Device That Records Heart Sounds Including Murmurs And Vibrations To Calculate A Patient-specific Risk Of Presence Of Coronary Artery Disease, As An Aid In Cardiac Analysis And Diagnosis.
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.