# K142935: CareEvent

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jan 15, 2015 after 98 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: 6 generations back to K962827 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102974: Intellisphere Event Managment System Rel. 10.00, Philips Medical Systems (2011) Summary page 4.

## Most influential descendants
- K161164: CareEvent inclusive of the CareEvent Mobile Application accessory (2016), 0 descendants of its own

## Indications for use
The intended use of the CareEvent solution is to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all of subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices. The CareEvent mobile application software provides healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). Receipt of alarm messages or events by the external mobile device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

Source page: https://510kreport.com/device/K142935
Methodology: https://510kreport.com/methodology