Cleared Traditional

K812863 - FETASONDE 5

K812863 is an FDA 510(k) clearance for FETASONDE 5, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K812863 · Kontron Instruments, Inc. · Obstetrics & Gynecology device
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Nov 1981
Decision
24d
Days
Class 2
Risk

K812863 is an FDA 510(k) clearance for the FETASONDE 5, #30, CENTRAL NURSING STAT. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 24 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K812863

510(k) Number K812863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1981
Decision Date November 06, 1981
Days to Decision 24 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
136d faster than avg
Panel avg: 160d · This submission: 24d
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 97
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K812863.
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