Cleared Special

HeRO Symphony, HeRO ES, HeRO solo/duet (K180242) - FDA 510(k) Clearance

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

K180242 · Medical Predictive Science Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
30d
Days
Class 2
Risk

K180242 is an FDA 510(k) clearance for the HeRO Symphony, HeRO ES, HeRO solo/duet. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medical Predictive Science Corporation (Charlottesville, US). The FDA issued a Cleared decision on February 28, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

View all Medical Predictive Science Corporation devices

Submission Details

510(k) Number K180242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date February 28, 2018
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 146
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K180242.
CheckMyHeart Plus
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MiCor A100 Wearable ECG Recorder
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Electrocardiograph
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CONTEC™ Electrocardiograph
K171360 · Contec Medical Systems Co.,Ltd · Jan 2018