# K160718: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Nov 14, 2016 after 244 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 9 generations back to K921669 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140339: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Covidien (2014) Summary page 4.
- K133882: Carescape Central Station (Formally Known as Cic Pro), Ge Medical Systems Information Technologies, Inc. (2014) Summary page 4.

## Recalls of this device
- Jan 30, 2026 · Class II · Z-1557-2026: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

## Indications for use
The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS). The Vital Sync™ Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data, waveforms, alarms and alerts routed through the Vital Sync™ Informatics Manager from supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals in a hospital or hospital-type facility for the following purposes: - To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management. - To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices. - To access additional processed parameters to facilitate patient monitoring, assessment and clinical management. - To set and adjust alert thresholds on supported devices where this capability is not available on the device itself. - To access data, waveforms and alerts from supported devices where these capabilities are not enabled or available on the device itself. WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are notification systems and are not replacements for direct patient observation, patient assessment or clinical judgment

Source page: https://510kreport.com/device/K160718
Methodology: https://510kreport.com/methodology