Cleared Traditional

K800858 - FETAL HEART DETECTOR #'S D102 & D102R

K800858 is an FDA 510(k) clearance for FETAL HEART DETECTOR #'S D102 & D102R, manufactured by Sonicaid, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K800858 · Sonicaid, Inc. · Obstetrics & Gynecology device
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May 1980
Decision
29d
Days
Class 2
Risk

K800858 is an FDA 510(k) clearance for the FETAL HEART DETECTOR #'S D102 & D102R. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 29 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.

View all Sonicaid, Inc. devices

FDA 510(k) Submission Details - K800858

510(k) Number K800858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1980
Decision Date May 14, 1980
Days to Decision 29 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
131d faster than avg
Panel avg: 160d · This submission: 29d
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.