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HERO, Version 2.0

by Medical Predictive Science Corp.

510(k) K081473

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081473 Date27 Jun 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HERO, Version 2.0 is a Cardiac Monitoring Device designed to acquire, store, analyze, and report electrocardiogram (ECG) data from infants. It functions as a diagnostic tool to continuously monitor heart rhythms in neonatal or pediatric intensive care settings, providing real-time cardiac assessment under direct healthcare supervision. This device supports early detection of arrhythmias or other cardiac abnormalities in high-risk infants.

The HERO, Version 2.0 is intended for use exclusively in hospital-based neonatal or pediatric intensive care units (ICUs) under the direct supervision of a licensed healthcare practitioner. It is supplied as a reusable medical device, with no specified sterility requirements beyond standard hospital disinfection protocols. The device complies with FDA 510(k) clearance (K081473) under the Cardiovascular advisory committee, classified under product code DPS. No MRI safety or single-use specifications are noted in the regulatory submission.

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