# K132604: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Dec 4, 2013 after 106 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122133 (2012). 2 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130796: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Covidien (2013) Summary page 1.

## Most influential descendants
- K140339: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform (2014), 22 descendants of its own
- K142732: T3 Software (2015), 18 descendants of its own
- K151715: T3 Software (2015), 17 descendants of its own
- K152258: T3 Software (2016), 16 descendants of its own
- K163065: T3 Software (2017), 15 descendants of its own

## Recalls of this device
- Jul 17, 2014 · Class II · Z-2235-2014: Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vita
- Jul 17, 2014 · Class II · Z-2234-2014: Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vita

## 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 Electronic Medical Record (eMR) and Clinical Information System (CIS). The Vital Sync Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync Informatics Manager for supported devices. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status - To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. WARNING: The Vital Sync Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync Informatics Manager & Virtual Patient Monitoring Platform as the sole source of alarms.

Source page: https://510kreport.com/device/K132604
Methodology: https://510kreport.com/methodology