Cleared Traditional

K946115 - EK-VIEW(TM) ECG MANAGEMENT SYSTEM

K946115 is an FDA 510(k) clearance for EK-VIEW(TM) ECG MANAGEMENT SYSTEM, manufactured by Apcot Medical Systems. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K946115 · Apcot Medical Systems · Cardiovascular device
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Mar 1995
Decision
76d
Days
Class 2
Risk

K946115 is an FDA 510(k) clearance for the EK-VIEW(TM) ECG MANAGEMENT SYSTEM. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Apcot Medical Systems (Philadelphia, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Apcot Medical Systems devices

FDA 510(k) Submission Details - K946115

510(k) Number K946115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date March 01, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 115
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K946115.
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