Cleared Traditional

FETASONDE 5, #30, CENTRAL NURSING STAT (K812863) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 28
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K812863.
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · Hewlett-Packard Co. · Aug 1989
OMF-7101 FETAL MONITOR
K860237 · Nihon Kohden America, Inc. · Sep 1986
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K861544 · Hewlett-Packard Co. · Jul 1986
TERUMO FETAL MONITOR # FHM-602
K801747 · Terumo Medical Corp. · Aug 1980
MODEL 80032A, OBSTETRICAL TELEMETRY
K781359 · Hewlett-Packard Co. · Sep 1978
MODEL 80100A, PATIENT DATA MEMORY
K781360 · Hewlett-Packard Co. · Sep 1978