# K172965: Handheld VitalSigns Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Visiomed Technology Co.,Ltd
- Decided: Dec 17, 2018 after 447 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962603 (1997). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150361: ViSi Mobile Monitoring System, Sotera Wireless, Inc. (2015) Summary page 5.

## Indications for use
The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient’s physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate. For measuring ECG, SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intended patient population is all types of people including newborn, pediatric and adult. The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

Source page: https://510kreport.com/device/K172965
Methodology: https://510kreport.com/methodology