# K041775: GE Datex-Ohmeda Engstrom Carestation

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Oct 26, 2004 after 117 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: 3 generations back to K902859 (1991). 11 ancestors in all.
107 later devices descend from it; 4 cite it directly.
37 of 119 devices in its family (counting itself) have 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.
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements, Datex-Ohmeda, Inc. (2003) Summary page 1.

## Most influential descendants
- K051767: LTV 1000 Ventilator (2005), 57 descendants of its own
- K051895: GE Datex-Ohmeda Engstrom Carestation (2005), 49 descendants of its own
- K060862: GE Datex-Ohmeda Engstrom Carestation (2006), 48 descendants of its own
- K062710: GE Datex-Ohmeda Engstrom Carestation (2006), 47 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own

## 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-VG) · 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 (CPAP/PSV) · Apnea backup (active in Bi-level and CPAP/PSV) The Engstrom Carestation includes integrated Oxygen, FiO2, airway pressure, spirometry and volume monitoring and an integrated Aerogen Aeroneb Pro nebulizer. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling. 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/K041775
Methodology: https://510kreport.com/methodology