Cleared Traditional

K012414 - PRIME ECG SYSTEM

K012414 is an FDA 510(k) clearance for PRIME ECG SYSTEM, manufactured by Meridian Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K012414 · Meridian Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
219d
Days
Class 2
Risk

K012414 is an FDA 510(k) clearance for the PRIME ECG SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Meridian Medical Technologies, Inc. (Columbia, US). The FDA issued a Cleared decision on March 6, 2002 after a review of 219 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 Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K012414

510(k) Number K012414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date March 06, 2002
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 334
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K012414.
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · Cambridge Heart, Inc. · Jul 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K022152 · Cambridge Heart, Inc. · Jul 2002
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · Philips Medical Systems, Inc. · Apr 2002
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · Cambridge Heart, Inc. · Nov 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · Cambridge Heart, Inc. · Nov 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
K010758 · Cambridge Heart, Inc. · Apr 2001