Cleared Traditional

COROMETRICS FETAL MOVEMENT DETECTION KIT (K955559) - FDA 510(k) Clearance

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

K955559 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Mar 1996
Decision
90d
Days
Class 2
Risk

K955559 is an FDA 510(k) clearance for the COROMETRICS FETAL MOVEMENT DETECTION KIT. 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 March 5, 1996 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

Submission Details

510(k) Number K955559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1995
Decision Date March 05, 1996
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.

Device Classification

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 56
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K955559.
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies · Nov 2001
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies · Feb 2000
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · Ge Medical Systems Information Technologies · Feb 1997
MODEL 118 FETAL/MATERNAL MONITOR
K934959 · Ge Medical Systems Information Technologies · Aug 1994
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co. · Aug 1994
MODEL 151 FETAL MONITOR
K932077 · Ge Medical Systems Information Technologies · Mar 1994