# K060862: GE Datex-Ohmeda Engstrom Carestation

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 5, 2006 after 68 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902859 (1991). 15 ancestors in all.
48 later devices descend from it; 1 cites it directly.
20 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051895: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2005) Summary page 1.

## Most influential descendants
- K062710: GE Datex-Ohmeda Engstrom Carestation (2006), 47 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own
- K093886: Engstrom Carestation, Engstrom Pro (2010), 21 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own

## Recalls of this device
- Feb 2, 2007 · Not classified · Z-0784-2007: There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit 

## Indications for use
The GE Datex-Ohmeda Engstrbm 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 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 GE Datex-Ohmeda Engstr6m 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 in the product labeling, an integrated air compressor, capabilities to measure SpiroDynamics via an intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/ash Out method. The Engstrbm Carestation is not a pulmonary function calculation device. 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/K060862
Methodology: https://510kreport.com/methodology