Cleared Special

K081473 - HERO, VERSION 2.0

K081473 is an FDA 510(k) clearance for HERO, manufactured by Medical Predictive Science Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 31-day FDA review.

K081473 · Medical Predictive Science Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
31d
Days
Class 2
Risk

K081473 is an FDA 510(k) clearance for the HERO, VERSION 2.0. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medical Predictive Science Corp. (Charlottesville, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 31 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.

FDA 510(k) Submission Details - K081473

510(k) Number K081473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date June 27, 2008
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

DPS Device Classification - Class 2, Special Controls

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 493
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K081473.
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
K082312 · Heartscape Technologies, Ltd. · Sep 2008
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MAC 1600 ECG ANALYSIS SYSTEM
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PAGEWRITER CARDIOGRAPH
K080999 · Philips Medical Systems · May 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · Medtechs, LLC · Apr 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · Ge Healthcare Systems Information Technologies · Jan 2008
K081473 · HERO, VERSION 2.0
Download PDF FDA Summary Medical Predictive Sc…