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CareEvent inclusive of the CareEvent Mobile Application accessory

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161164

by Philips Medical Systems

Identifiers

510(k) Number
K161164 FDA 510(k)
FDA Product Code
MSX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CareEvent is a networked system for managing and communicating medical device events, including physiological alarms, technical alarms, clinical notifications, nurse call alarms, and informational messages. It functions as an enterprise event management solution designed to consolidate and relay critical alerts to healthcare professionals in real time, ensuring timely clinical decision-making.

The system is supplied as a reusable, non-sterile device intended for use in clinical settings such as hospitals and healthcare facilities. It integrates with existing medical infrastructure and supports wireless communication via the included Mobile Application accessory, which delivers alerts to end-user devices. Regulated under FDA 510(k) clearance and the Medical Device Directive (MDD), CareEvent operates within Class II device classification (FDA: 870.2300) and is intended for cardiovascular monitoring applications.

Frequently asked questions

What is the primary purpose of the CareEvent system in a clinical setting?

The CareEvent system is designed to manage and communicate critical medical device events, such as physiological alarms, technical alarms, clinical notifications, nurse call alarms, and informational messages. It consolidates these alerts in real time, ensuring healthcare professionals receive timely updates to support clinical decision-making, particularly in cardiovascular monitoring applications.

Is the CareEvent system reusable or single-use, and what are its sterility requirements?

CareEvent is supplied as a reusable, non-sterile device. Since it is intended for integration into clinical infrastructure and not direct patient contact, sterility is not a requirement, but proper cleaning and maintenance protocols must be followed to ensure reliable operation in healthcare settings.

How does the CareEvent Mobile Application accessory enhance the functionality of the system?

The CareEvent Mobile Application accessory enables wireless communication, allowing critical alerts to be delivered directly to end-user devices (such as smartphones or tablets). This ensures healthcare professionals can receive real-time notifications regardless of their location within the facility, improving responsiveness and coordination.

What regulatory pathways does CareEvent follow, and what classification does it hold?

CareEvent is regulated under both the FDA’s 510(k) clearance process and the Medical Device Directive (MDD). It is classified as a Class II device under FDA regulation (870.2300) and is intended for use in cardiovascular monitoring applications, though the classification itself is based on the submission’s filing category rather than a direct clinical indication.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips - CareEvent Event management system, CareEvent inclusive of the CareEvent Mobile Application accessory ..., Philips - CareEvent Event management system

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (2)

  • FDA 510(k) K161164 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026