# K151839: AMC Health VitalCaregiving System

- Pathway: 510(k) (Traditional)
- Applicant: Amc Health
- Decided: Sep 9, 2016 after 431 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: 7 generations back to K910772 (1991). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051544: Vitalcaregiving System, Advanced Monitoring Caregiving, Inc. (2005) Summary page 5.
- K133450: Airstrip Remote Patient Monitoring, Airstrip Technologies, LP (2014) Summary page 5.

## Most influential descendants
- K233446: AMC Health CareConsole (2024), 0 descendants of its own

## Indications for use
The AMC Health VitalCaregiving System II (“VitalCaregiving System II”) is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and store data, and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition. • Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices. • The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging. The VitalCaregiving System II is not intended for use in emergency situations or by a patient in an acute care medical facility and is not for active patient monitoring.

Source page: https://510kreport.com/device/K151839
Methodology: https://510kreport.com/methodology