510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K890139Substantially Equivalent

Toitu Doppler Fetus Detector, Fd-400D

Toitu of America, Inc., Wayne PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890139 is the FDA 510(k) clearance record for TOITU DOPPLER FETUS DETECTOR, FD-400D, a class II device, cleared for Toitu of America, Inc. on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 2 510(k) clearances for Toitu of America, Inc., from to . As of , FDA records show no recalls naming K890139.

Clearance record

Decision date
Received
(75 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Toitu of America, Inc. 983 Old Eagle School Rd., Wayne PA
Third party review
No

Clearances, product code KNG

Trailing 12 months
1 clearance under product code KNG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260