# K050860: GE Datex-Ohmeda Centiva/5 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 21, 2005 after 77 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K902859 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992608: Atc Option for Evita 2 Dura and Evita 4, Drager, Inc. (1999) Summary page 1.
- K970165: Evita 2 Dura, Drager, Inc. (1997) Summary page 1.
- K041775: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2004) Summary page 1.

## Indications for use
The GE Datex-Ohmeda Centiva/5 Critical Care Ventilator is designed as a critical care ventilator for adult to pediatric patients. It provides volume control, pressure volume, bi-level and pressure support ventilation (PSV), Continuous Positive Pressure (CPAP) and PSV with apnea back-up ventilation modes. It incorporates integrated airway pressure, patient flow, tidal volume, minute volume, peak pressure, PEEP, rate and FlO2 monitoring. The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Source page: https://510kreport.com/device/K050860
Methodology: https://510kreport.com/methodology