Cleared Traditional

MONITOR, OFFICE MODEL 140 (K790139) - FDA 510(k) Clearance

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

K790139 · Ge Medical Systems Information Technologies · Radiology device
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Feb 1979
Decision
28d
Days
Class 2
Risk

K790139 is an FDA 510(k) clearance for the MONITOR, OFFICE MODEL 140. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on February 16, 1979 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2740 - the FDA radiology and imaging software 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: 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 K790139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1979
Decision Date February 16, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
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 Radiology 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 K790139.
COROMETRICS 815 FETAL ECG RECORDER
K841477 · Ge Medical Systems Information Technologies · May 1984
FETAL MONITOR #115
K831852 · Ge Medical Systems Information Technologies · Aug 1983
TERUMO FETAL MONITOR # FHM-602
K801747 · Terumo Medical Corp. · Aug 1980
MODEL 80032A, OBSTETRICAL TELEMETRY
K781359 · Hewlett-Packard Co. · Sep 1978
MODEL 80100A, PATIENT DATA MEMORY
K781360 · Hewlett-Packard Co. · Sep 1978
DISPLAY SYSTEM MODEL 428
K780176 · Ge Medical Systems Information Technologies · Mar 1978