# K150869: Checkme Pro Health Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Viatom Technology Co., Ltd.
- Decided: Dec 10, 2015 after 253 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: 16 generations back to K941811 (1994). 106 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131762: Handheld Monitor, Guangdong Biolight Meditech Co., Ltd. (2014) Summary page 4.
- K062894: Instantcheck RTD-Ecg Monitor, Model RMH4.0, Dailycare Biomedical, Inc. (2007) Summary page 4.
- K100953: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1, Microlife Intellectual Property GmbH (2010) Summary page 4.

## Most influential descendants
- K191088: Checkme O2 Pulse Oximeter (2019), 2 descendants of its own
- K242876: Pulse Oximeter ( PO2, PO2A, PO2B) (2025), 0 descendants of its own
- K213515: WesperO2 (2022), 0 descendants of its own
- K201635: MouthLab Vital Signs Monitoring System (2021), 0 descendants of its own
- K190090: DynoSense Vital Sign Measuring System (2019), 0 descendants of its own

## Indications for use
The Checkme Pro Health Monitor is intended to be used for measuring, displaying, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities. This device is not intended to substitute for a hospital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).

Source page: https://510kreport.com/device/K150869
Methodology: https://510kreport.com/methodology