# K033283: Centra View Device Link System

- Pathway: 510(k) (Traditional)
- Applicant: Icu Datasystems, Inc.
- Decided: Oct 27, 2003 after 13 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
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093422: Vital Sync Model 5000 Series (2010), 19 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

## Indications for use
The CentraView patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and @attic patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices. CentmView is not intended for monitoring purposes, nor is it intended to control any of the independent bedside devices it is connected to. The CentraView System: Is intended for use on neonatal, @atric and adult patients. Is intended for use in critical care environments by trained healthcare providers. Does not require direct patient contact. Is a prescription device which restricts its sale andor use except by the order of a physician.

Source page: https://510kreport.com/device/K033283
Methodology: https://510kreport.com/methodology