Cleared Traditional

OMF-7101 FETAL MONITOR (K860237) - FDA 510(k) Clearance

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

K860237 · Nihon Kohden America, Inc. · Obstetrics & Gynecology device
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Sep 1986
Decision
225d
Days
Class 2
Risk

K860237 is an FDA 510(k) clearance for the OMF-7101 FETAL MONITOR. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on September 5, 1986 after a review of 225 days - an extended review 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: 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 Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K860237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1986
Decision Date September 05, 1986
Days to Decision 225 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
65d slower than avg
Panel avg: 160d · This submission: 225d
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 55
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K860237.
MODEL 116 FETAL MONITOR
K891595 · Ge Medical Systems Information Technologies · Jun 1989
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
K882966 · Ge Medical Systems Information Technologies · Oct 1988
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K880419 · Ge Medical Systems Information Technologies · Jun 1988
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · Hewlett-Packard Co. · Jul 1986
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