Cleared Traditional

K890139 - TOITU DOPPLER FETUS DETECTOR, FD-400D

K890139 is an FDA 510(k) clearance for TOITU DOPPLER FETUS DETECTOR, manufactured by Toitu of America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K890139 · Toitu of America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Mar 1989
Decision
75d
Days
Class 2
Risk

K890139 is an FDA 510(k) clearance for the TOITU DOPPLER FETUS DETECTOR, FD-400D. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Toitu of America, Inc. (Wayne, US). The FDA issued a Cleared decision on March 29, 1989 after a review of 75 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 Toitu of America, Inc. devices

FDA 510(k) Submission Details - K890139

510(k) Number K890139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date March 29, 1989
Days to Decision 75 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
85d faster than avg
Panel avg: 160d · This submission: 75d
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 40
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K890139.
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PROGRAMALITH PROGRAMMER
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