510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050395Substantially Equivalent

Impedimed - Body Composition Analysis

Impedimed, Inc., Brisbane, Queensland, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050395 is the FDA 510(k) clearance record for IMPEDIMED - BODY COMPOSITION ANALYSIS, a class II device, cleared for Impedimed Pty , Ltd. on under FDA product code MNW (Analyzer, Body Composition). FDA records list 16 510(k) clearances for Impedimed Pty , Ltd., from to . As of , FDA records show no recalls naming K050395.

Clearance record

Decision date
Received
(147 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Impedimed Pty , Ltd. Bldg. 4b/2404 Logan Rd., Brisbane, Queensland, AU
510(k) summary
Summary PDF
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