# K201635: MouthLab Vital Signs Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Multisensor Diagnostics (Dba Aidar Health)
- Decided: Feb 6, 2021 after 235 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: 18 generations back to K962603 (1997). 188 ancestors in all.
No later device cites it as a predicate yet.
1 of 189 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150869: Checkme Pro Health Monitor, Viatom Technology Co., Ltd. (2015) Summary page 4.
- K171621: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor, Welch Allyn, Inc. (2017) Summary page 4.
- K152276: Wing Smart FEVI and Peak Flow Meter, Sparo, Inc. (2016) Summary page 4.

## Indications for use
The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate (HR), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1). This system is for spot checking and does not have continuous monitoring capability or any alarm features. The device comes in contact with the user for approximately 60 seconds at each use and the captured medical parameters shall be displayed on a mobile application. It is intended for use by adults in the home environment and in healthcare facilities. This system makes no specific diagnosis. Respiration rate is not intended for adults with underlying or suspected medical conditions. The device is for single user use. It is intended for use with users who are well perfused and during no motion condition. Users with implanted pacemakers and/or implanted cardioverter-defibrillators (ICDs) are not recommended to use the device.

Source page: https://510kreport.com/device/K201635
Methodology: https://510kreport.com/methodology