Cleared Traditional

K092369 - 12SL ECG ANALYSIS PROGRAM

K092369 is an FDA 510(k) clearance for 12SL ECG ANALYSIS PROGRAM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K092369 · Ge Medical Systems Information Technologies · Cardiovascular device
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Feb 2010
Decision
203d
Days
Class 2
Risk

K092369 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 (Wauwatosa, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 203 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 devices

FDA 510(k) Submission Details - K092369

510(k) Number K092369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date February 24, 2010
Days to Decision 203 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K092369.
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
K101067 · Philips Medical Systems · May 2010
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90
K100939 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Apr 2010
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K093788 · Draeger Medical Systems, Inc. · Mar 2010
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
K093501 · Spacelabs Medical, Inc. · Nov 2009
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN
K092680 · GE Healthcare Finland Oy · Sep 2009
CARESCAPE MONITOR B850
K092027 · Ge Medical Systems Information Technologies · Aug 2009