# K093422: Vital Sync Model 5000 Series

- Pathway: 510(k) (Traditional)
- Applicant: Somanetics Corp.
- Decided: Apr 29, 2010 after 177 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: 1 generation back to K033283 (2003). 1 ancestor in all.
19 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033283: Centra View Device Link System, Icu Datasystems, Inc. (2003) 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'TM System is intended for 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. Vital Sync System displayed parameters are listed on the following pages.

Source page: https://510kreport.com/device/K093422
Methodology: https://510kreport.com/methodology