Cleared Traditional

K831371 - MODEL FM5

K831371 is an FDA 510(k) clearance for MODEL FM5, manufactured by Sonicaid, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K831371 · Sonicaid, Inc. · Obstetrics & Gynecology device
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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

FDA 510(k) Submission Details - K831371

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
Combination Product No
PCCP Authorized No
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.

HGM Device Classification - Class 2, Special Controls

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 122
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K831371.
COROMETRICS 815 FETAL ECG RECORDER
K841477 · Ge Medical Systems Information Technologies · May 1984
FETAL MONITOR #FM-2
K832849 · Advantage Medical Systems, Inc. · Oct 1983
FETAL MONITOR #115
K831852 · Ge Medical Systems Information Technologies · Aug 1983
M2100 ANTEPARTUM FETAL MONITOR
K823081 · Huntleigh Technology, Inc. · Jan 1983
M2000 INTRAPARTUM FETAL MONITOR
K823188 · Huntleigh Technology, Inc. · Jan 1983
TELEPHONE LINK DATA TRANSMISSION SYS
K821478 · Advantage Medical Systems, Inc. · Jul 1982