# K091369: Electrofluidgraph

- Pathway: 510(k) (Traditional)
- Applicant: Akern USA, LLC
- Decided: Oct 14, 2009 after 159 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ElectroFluidGraph™ is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in "generally healthy" subjects of 21 to 87 years old.

Source page: https://510kreport.com/device/K091369
Methodology: https://510kreport.com/methodology