# K123002: Vital Sync System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Decided: Feb 27, 2013 after 153 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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: 4 generations back to K991684 (2000). 5 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093244: Unique Temp Warming Blankets, Model 8001140XXX, Geratherm Medical AG (2010) Summary page 1.

## Most influential descendants
- 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
- K190273: T3 Platform software (2019), 14 descendants of its own

## Indications for use
The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to. The Vital Sync™ System displayed parameters are listed on the following pages. WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring.

Source page: https://510kreport.com/device/K123002
Methodology: https://510kreport.com/methodology