# K050597: GE Datex-Ohmeda Engstrom Carestation

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 25, 2005 after 16 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). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041775: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K023354: Compressor Mini, 115 V, Model 64 81 779 EH81E, Siemens Elema AB (2003) Summary page 1.

## Indications for use
The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include: • Volume Controlled (VCV) * Pressure Controlled (PCV) * Pressure Controlled, Volume Guaranteed (PCV.M/G) * Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC) *Bi-level Airway Pressure Ventilation Constant Positive Airway Pressure/Pressure Support Ventilation (CPAPLPSV) Apnea backup (active in Bi-level and CPAP/PSV) The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed inthe product labeling and an integrated air compressor. 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/K050597
Methodology: https://510kreport.com/methodology