# K160951: Philips Efficia CMS200 Central Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: May 5, 2016 after 30 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K941811 (1994). 139 ancestors in all.
No later device cites it as a predicate yet.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131032: Philips Suresigns Central, Philips Medical Systems (2013) Summary page 5.

## Recalls of this device
- Jan 17, 2017 · Class II · Z-1229-2017: The monitor may not alarm appropriately for a pediatric or neonatal patient.

## Indications for use
The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

Source page: https://510kreport.com/device/K160951
Methodology: https://510kreport.com/methodology