510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091369Substantially Equivalent

Electrofluidgraph

Akern USA, LLC, Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091369 is the FDA 510(k) clearance record for ELECTROFLUIDGRAPH, a class II device, cleared for Akern USA, LLC on under FDA product code MNW (Analyzer, Body Composition). FDA records list one 510(k) clearance for Akern USA, LLC. As of , FDA records show no recalls naming K091369.

Clearance record

Decision date
Received
(159 days to decision)
Product code
MNW Analyzer, Body Composition
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Akern USA, LLC 5401 S Cottonwood Ct., Greenwood Village CO
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