510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K911453Substantially Equivalent

Obtrasound Stethoscope Fetal Calc

Medasonics, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911453 is the FDA 510(k) clearance record for OBTRASOUND STETHOSCOPE FETAL CALC, a class II device, cleared for Medasonics, Inc. on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 19 510(k) clearances for Medasonics, Inc., from to . As of , FDA records show no recalls naming K911453.

Clearance record

Decision date
Received
(78 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medasonics, Inc. 47233 Fremont Blvd., Fremont CA
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