Cleared Traditional

K113234 - MOBCARDIO SYSTEM

K113234 is an FDA 510(k) clearance for MOBCARDIO SYSTEM, manufactured by Mobhealth Incorporation. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K113234 · Mobhealth Incorporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
15d
Days
Class 2
Risk

K113234 is an FDA 510(k) clearance for the MOBCARDIO SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mobhealth Incorporation (Temple City, US). The FDA issued a Cleared decision on November 17, 2011 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mobhealth Incorporation devices

FDA 510(k) Submission Details - K113234

510(k) Number K113234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date November 17, 2011
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 283
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K113234.
RSCRIBE ELECTROCARDIOGRAPH
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ELECTROCARDIOGRAPH
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MAC 600 RESTING ECG ANALYSIS SYSTEM
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K110266 · Ge Medical Systems Information Technologies, Inc. · Apr 2011