# K210086: Vitals360 Multi-Vitals Mobile Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Vocare, Inc.
- Decided: May 20, 2021 after 127 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: 13 generations back to K941811 (1994). 122 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 127 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170047: All-in-One Health Monitor, PC-303, Shenzhen Creative Industry Co., Ltd. (2017) Summary page 4.
- K200578: Infrared Thermometer Model Number RN-50A,RN-50B, Ningbo Ranor Medical Science & Technology Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K212975: MedWand (2022), 1 descendant of its own
- K253436: c-med0 alpha (2026), 0 descendants of its own
- K231116: Multi-parameter detector (2024), 0 descendants of its own
- K222330: The Heart Seat (2023), 0 descendants of its own

## Indications for use
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age. This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently. This VITALS360® device is intended for use in a clinical or home environment. This VITALS360® device is a reusable device following thorough cleaning between uses.

Source page: https://510kreport.com/device/K210086
Methodology: https://510kreport.com/methodology