Cleared Traditional

K103077 - ECG PEN

K103077 is an FDA 510(k) clearance for ECG PEN, manufactured by Meridian Dynamics Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K103077 · Meridian Dynamics Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
268d
Days
Class 2
Risk

K103077 is an FDA 510(k) clearance for the ECG PEN. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Meridian Dynamics Biomedical, Inc. (Flagstaff, US). The FDA issued a Cleared decision on July 13, 2011 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Meridian Dynamics Biomedical, Inc. devices

FDA 510(k) Submission Details - K103077

510(k) Number K103077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date July 13, 2011
Days to Decision 268 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K103077.
ECG SERIES ELECTROCARDIOGRAPH
K111805 · Advanced Instrumentations, Inc. · Aug 2011
ECG-6 SERIES ELECTROCARDIOGRAPH
K112135 · Advanced Instrumentations, Inc. · Aug 2011
ACG-8511 PORTABLE ECG MONITOR
K110328 · Andon Health Co, Ltd. · Jul 2011
MAC 600 RESTING ECG ANALYSIS SYSTEM
K103765 · Ge Medical Systems Information Technologies, Inc. · May 2011
MAC 5500 HD, MAC 3500
K110266 · Ge Medical Systems Information Technologies, Inc. · Apr 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · Taidoc Technology Corporation · Mar 2011