# K211046: eCareManager 4.5

- Pathway: 510(k) (Traditional)
- Applicant: Visicu, Inc.
- Decided: Jun 3, 2022 after 421 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 5.

## Indications for use
The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. The eCareManager software is solely indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.

Source page: https://510kreport.com/device/K211046
Methodology: https://510kreport.com/methodology