Cleared Traditional

MODEL FM5 (K831371) - FDA 510(k) Clearance

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

K831371 · Sonicaid, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
64d
Days
Class 2
Risk

K831371 is an FDA 510(k) clearance for the MODEL FM5. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 64 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 Sonicaid, Inc. devices

Submission Details

510(k) Number K831371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1983
Decision Date June 30, 1983
Days to Decision 64 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
96d faster than avg
Panel avg: 160d · This submission: 64d
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 K831371.
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
TERUMO FETAL MONITOR # FHM-602
K801747 · Terumo Medical Corp. · Aug 1980
MONITOR, OFFICE MODEL 140
K790139 · Ge Medical Systems Information Technologies · Feb 1979
MODEL 80032A, OBSTETRICAL TELEMETRY
K781359 · Hewlett-Packard Co. · Sep 1978