510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851902Substantially Equivalent

Model U-1000 Ultrasonic Scanner

Fukuda Denshi USA, Inc., Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851902 is the FDA 510(k) clearance record for MODEL U-1000 ULTRASONIC SCANNER, a class II device, cleared for Fukuda Denshi USA, Inc. on under FDA product code HEM (Imager, Ultrasonic Obstetric-Gynecologic). FDA records list 68 510(k) clearances for Fukuda Denshi USA, Inc., from to . As of , FDA records show no recalls naming K851902.

Clearance record

Decision date
Received
(150 days to decision)
Product code
HEM Imager, Ultrasonic Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Fukuda Denshi USA, Inc. 12539 130th Ln. Ne, Kirkland WA
Third party review
No

Clearances, product code HEM

Trailing 12 months

FDA records hold no clearances under product code HEM in the trailing twelve months.

FDA records show no clearances under product code HEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260