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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 471
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K113234.
ELECTROCARDIOGRAPH
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K111159 · Cardiocomm Solutions, Inc. · Dec 2011
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
K102378 · Vectracor, Inc. · Nov 2011
PHYSIOGLOVE ES WITH ECG ANALYSIS
K103791 · Commwell , Ltd. · Oct 2011
DIGITAL ELECTROCARDIOGRAPH
K112431 · Shenzhen Biocare Electronics Co., Ltd. · Sep 2011