Cleared Traditional

12SL ECG ANALYSIS PROGRAM (K141963) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141963 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device
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Feb 2015
Decision
202d
Days
Class 2
Risk

K141963 is an FDA 510(k) clearance for the 12SL ECG ANALYSIS PROGRAM. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on February 5, 2015 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number K141963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2014
Decision Date February 05, 2015
Days to Decision 202 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
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 169
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K141963.
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V Series Monitoring System (including V12 and V21 Monitors)
K150352 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2015
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
K123074 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2013
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2010
12SL ECG ANALYSIS PROGRAM
K092369 · Ge Medical Systems Information Technologies · Feb 2010