Cleared Traditional

K790951 - SA/7860 FETAL HEART MONITOR (DOPPLER)

K790951 is an FDA 510(k) clearance for SA/7860 FETAL HEART MONITOR (DOPPLER), manufactured by Schlosser Alberti Co.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K790951 · Schlosser Alberti Co. · Obstetrics & Gynecology device
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Aug 1979
Decision
74d
Days
Class 2
Risk

K790951 is an FDA 510(k) clearance for the SA/7860 FETAL HEART MONITOR (DOPPLER). Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Schlosser Alberti Co. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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.

FDA 510(k) Submission Details - K790951

510(k) Number K790951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1979
Decision Date August 03, 1979
Days to Decision 74 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
87d faster than avg
Panel avg: 161d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - KNG Monitor, Ultrasonic, Fetal

All 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K790951.
FETAL HEART DETECTOR #D206
K800859 · Sonicaid, Inc. · May 1980
MGD-3
K800095 · Kt Medical, Inc. · Feb 1980
MINIFETON 200
K800098 · Kt Medical, Inc. · Feb 1980
PROBE, BLOOD FLOW DETECTOR PLUG-IN
K770904 · Medsonics · May 1977
MODEL 6/60 CRT VIDEO-SONAR
K760888 · Vexilar, Inc. · Feb 1977
CONTINUOUS WAVE DOPPLER ULTRASOUND
K760728 · Medsonics · Oct 1976
K790951 · SA/7860 FETAL HEART MONITOR (DOPPLER)
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