# K190090: DynoSense Vital Sign Measuring System

- Pathway: 510(k) (Traditional)
- Applicant: Dynosense Corp.
- Decided: Aug 2, 2019 after 197 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: 17 generations back to K962603 (1997). 174 ancestors in all.
No later device cites it as a predicate yet.
1 of 175 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.
- K132808: Vital Signs Monitor, Connex Vital Signs Monitor, Welch Allyn, Inc. (2013) Summary page 4.

## Indications for use
The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG), heart rate (HR), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features. This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition. This system makes no specific diagnosis. The device is for single patient use. Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device.

Source page: https://510kreport.com/device/K190090
Methodology: https://510kreport.com/methodology