# K210160: AlertWatch:AC

- Pathway: 510(k) (Traditional)
- Applicant: Alertwatch, Inc.
- Decided: Sep 10, 2021 after 232 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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: 34 generations back to K941811 (1994). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171322: eCareManager 4.1, Visicu, Inc. (2017) Summary page 4.

## Indications for use
AlertWatch:AC is intended for use by physicians for secondary monitoring of ICU patients. AlertWatch:AC is also intended for use by physicians providing supplemental remote support to bedside care teams in the management and care of ICU patients. AlertWatch:AC is not intended for use in monitoring pediatric or neonatal patients. AlertWatch:AC is a software system that combines data from the electronic medical record, networked physiologic monitors, and ancillary systems, and displays them on a dashboard view of the unit and patient. The clinical decision support is generated to aid in understanding the patient’s current condition and changes over time. Once alerted by AlertWatch:AC, the physician must refer to the primary monitor, device, or data source before making a clinical decision.

Source page: https://510kreport.com/device/K210160
Methodology: https://510kreport.com/methodology