# K031582: Wrist Blood Pressure Monitor & Fat Meter, Model WT-20

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Aug 1, 2003 after 72 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 K003444 (2000). 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)
- K011652: Body Fat Analyzer, Model HBF-306, Omron Healthcare, Inc. (2001)
- K003444: Model WS-500 Digital Wrist Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. (2000) Summary page 1.

## Indications for use
Combination unit for measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 4.9” to 8’’ inches as well as body composition, i.e. estimation of body fat, a noninvasive bioimpedance analyzer for use in estimating the human’s body fat volume (mass) and percentage by weight. Age range 10-80 years normal subjects, 18-80 years for athletic subjects.

Source page: https://510kreport.com/device/K031582
Methodology: https://510kreport.com/methodology