Cleared Traditional

K843385 - COROMETRICS 115 FETAL MONITOR

K843385 is an FDA 510(k) clearance for COROMETRICS 115 FETAL MONITOR, 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 93-day FDA review.

K843385 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Nov 1984
Decision
93d
Days
Class 2
Risk

K843385 is an FDA 510(k) clearance for the COROMETRICS 115 FETAL MONITOR. 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 29, 1984 after a review of 93 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 - K843385

510(k) Number K843385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date November 29, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 160d · This submission: 93d
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 K843385.
MODEL 145 FETAL MONITOR
K852076 · Ge Medical Systems Information Technologies · Jul 1985
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
K851252 · Ge Medical Systems Information Technologies · May 1985
COROMETRICS FETAL MONITOR 142
K843918 · Ge Medical Systems Information Technologies · Dec 1984
COROMETRICS 815 FETAL ECG RECORDER
K841477 · Ge Medical Systems Information Technologies · May 1984
FETAL MONITOR #115
K831852 · Ge Medical Systems Information Technologies · Aug 1983
FETASONDE 5, #30, CENTRAL NURSING STAT
K812863 · Kontron Instruments, Inc. · Nov 1981