510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043060Substantially Equivalent

Omron Fat Loss Monitor with Scale, Model Hbf-400

Omron Healthcare Co., Ltd., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043060 is the FDA 510(k) clearance record for OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400, a class II device, cleared for Omron Healthcare, Inc. on under FDA product code MNW (Analyzer, Body Composition). FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K043060.

Clearance record

Decision date
Received
(75 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Omron Healthcare, Inc. 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Statement
Third party review
No

Clearances, product code MNW

Trailing 12 months

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

FDA records show no clearances under product code MNW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNW, 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