Cleared Traditional

MODIFICATION FETAL MONITOR MODEL FM-2 (K852518) - FDA 510(k) Clearance

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

K852518 · Advantage Medical Systems, Inc. · Obstetrics & Gynecology device
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Jul 1985
Decision
23d
Days
Class 2
Risk

K852518 is an FDA 510(k) clearance for the MODIFICATION FETAL MONITOR MODEL FM-2. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Advantage Medical Systems, Inc. (Hamden, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 23 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 Advantage Medical Systems, Inc. devices

Submission Details

510(k) Number K852518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date July 05, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 160d · This submission: 23d
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 57
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K852518.
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
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 115 FETAL MONITOR
K843385 · Ge Medical Systems Information Technologies · Nov 1984