# K014009: Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale

- Pathway: 510(k) (Traditional)
- Applicant: Tanita Corp. of America
- Decided: Jun 24, 2002 after 201 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: 1 generation back to K930599 (1994). 1 ancestor in all.
38 later devices descend from it; 6 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930599: Body Fat Analyzer Model TBF-105, Tanita Corp. of America (1994) Summary page 1.

## Most influential descendants
- K040778: Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) (2004), 27 descendants of its own
- K033157: Tanita Segmental Body Composition Analyzer, Model BC-418 (2004), 15 descendants of its own
- K062652: Innerscan Body Composition Monitor, Innerscan Segmental Body Composition Monitor (2006), 7 descendants of its own
- K083838: Scaleman Body Fat Scales, Model: FS-148BW1 Series (2009), 6 descendants of its own
- K062603: Biospace Body Composition Analyzers, Model Inbody 230 (2007), 6 descendants of its own

## Indications for use
MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350: A body composition analyzer that measures body weight and impedance and estimates body fat percent, BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis). MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001: A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).

Source page: https://510kreport.com/device/K014009
Methodology: https://510kreport.com/methodology