Cleared Traditional

K802024 - GRAVIDAPHONE

K802024 is an FDA 510(k) clearance for GRAVIDAPHONE, manufactured by Solar Electronics. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K802024 · Solar Electronics · Obstetrics & Gynecology device
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Jan 1981
Decision
140d
Days
Class 2
Risk

K802024 is an FDA 510(k) clearance for the GRAVIDAPHONE. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Solar Electronics (Mchenry, US). The FDA issued a Cleared decision on January 7, 1981 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K802024

510(k) Number K802024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date January 07, 1981
Days to Decision 140 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
21d faster than avg
Panel avg: 161d · This submission: 140d
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 56
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K802024.
PROGRAMALITH PROGRAMMER
K823242 · Pacesetter Systems · Jan 1983
FETAL PULSE DETECTORS, F50/F60
K812868 · South Carolina Medical, Inc. · Nov 1981
DOPPLEX-PLB & PXB
K810115 · Huntleigh Technology, Inc. · Jul 1981
FETAL HEART DETECTOR #'S D102 & D102R
K800858 · Sonicaid, Inc. · May 1980
FETAL HEART DETECTOR #D206
K800859 · Sonicaid, Inc. · May 1980
PROBE, BLOOD FLOW DETECTOR PLUG-IN
K770904 · Medsonics · May 1977
K802024 · GRAVIDAPHONE
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