Cleared Traditional

K012718 - MODIFICATION TO COROMETRICS MODEL 120IS...

K012718 is an FDA 510(k) clearance for MODIFICATION TO COROMETRICS MODEL 120IS..., manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012718 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Nov 2001
Decision
90d
Days
Class 2
Risk

K012718 is an FDA 510(k) clearance for the MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on November 13, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device 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 Obstetrics & Gynecology 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 - K012718

510(k) Number K012718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2001
Decision Date November 13, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 99
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K012718.
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
K023931 · Philips Medical Systems, Inc. · Feb 2003
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K021574 · Card Guard Scientific Survival , Ltd. · Aug 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · Ge Medical Systems Information Technologies · May 2002
OB-1 FETAL MONITOR
K011304 · Analogic Corp. · May 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · Card Guard Scientific Survival , Ltd. · May 2001
FETALGARD LITE
K002503 · Analogic Corp. · Nov 2000