Cleared Traditional

K120770 - QT GUARD PLUS ANALYSIS SYSTEM

K120770 is an FDA 510(k) clearance for QT GUARD PLUS ANALYSIS SYSTEM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K120770 · Ge Medical Systems Information Technologies · Cardiovascular device
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Dec 2012
Decision
267d
Days
Class 2
Risk

K120770 is an FDA 510(k) clearance for the QT GUARD PLUS ANALYSIS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on December 6, 2012 after a review of 267 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K120770

510(k) Number K120770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2012
Decision Date December 06, 2012
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K120770.
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K131573 · Welch Allyn, Inc. · Jul 2013
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K122073 · Mortara Instrument, Inc. · Aug 2012
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K112622 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2012
RSCRIBE ELECTROCARDIOGRAPH
K120865 · Mortara Instrument, Inc. · Jul 2012