# K024077: Delwa-Star WS-FM Blood Pressure and Body Fat Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Zewa, Inc.
- Decided: Mar 10, 2003 after 90 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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
The Delwa-Star@ WS-FM Blood Pressure and Body Fat Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the wrist. The device is also intended to estimate body fat by bioelectrical impedance analysis.

Source page: https://510kreport.com/device/K024077
Methodology: https://510kreport.com/methodology