Cleared Traditional

COROMETRICS FETAL MONITOR 142 (K843918) - FDA 510(k) Clearance

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

K843918 · Ge Medical Systems Information Technologies · Obstetrics & Gynecology device
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Dec 1984
Decision
73d
Days
Class 2
Risk

K843918 is an FDA 510(k) clearance for the COROMETRICS FETAL MONITOR 142. 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 December 17, 1984 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K843918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date December 17, 1984
Days to Decision 73 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
87d faster than avg
Panel avg: 160d · This submission: 73d
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 K843918.
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
K852608 · Ge Medical Systems Information Technologies · Sep 1985
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 115 FETAL MONITOR
K843385 · Ge Medical Systems Information Technologies · Nov 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