# K233446: AMC Health CareConsole

- Pathway: 510(k) (Traditional)
- Applicant: Amc Health
- Decided: Sep 27, 2024 after 344 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: 8 generations back to K910772 (1991). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151839: AMC Health VitalCaregiving System, Amc Health (2016) Summary page 5.
- K051544: Vitalcaregiving System, Advanced Monitoring Caregiving, Inc. (2005) Summary page 5.
- K133450: Airstrip Remote Patient Monitoring, Airstrip Technologies, LP (2014) Summary page 5.

## Indications for use
CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform 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 healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition. • Data can be sent via intranet networks, the internet, landline telephones, cellular telephones, and other mobile devices. • The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages. CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.

Source page: https://510kreport.com/device/K233446
Methodology: https://510kreport.com/methodology