Cleared Special

K111601 - HERO

K111601 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 30-day FDA review.

K111601 · Medical Predictive Science Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
30d
Days
Class 2
Risk

K111601 is an FDA 510(k) clearance for the HERO. 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 July 8, 2011 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 Corp. devices

FDA 510(k) Submission Details - K111601

510(k) Number K111601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2011
Decision Date July 08, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
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 327
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K111601.
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K101569 · Taidoc Technology Corporation · Mar 2011