# K040978: Tanita Scale Plus Body Fat Monitor with Body Water Percentage

- Pathway: 510(k) (Traditional)
- Applicant: Tanita Corp. of America
- Decided: Jul 22, 2004 after 98 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
Longest line of descent: 2 generations back to K930599 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014009: Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale, Tanita Corp. of America (2002) Summary page 1.

## Indications for use
A body composition analyzer that measures body weight and impedance and estimates percentage of body fat and body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.

Source page: https://510kreport.com/device/K040978
Methodology: https://510kreport.com/methodology