# K062710: GE Datex-Ohmeda Engstrom Carestation

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Dec 8, 2006 after 88 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902859 (1991). 21 ancestors in all.
47 later devices descend from it; 3 cite it directly.
20 of 69 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.
- K060862: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2006) Summary page 1.
- K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 1.
- K041122: Precision Liquid Oxygen System, Precision Medical, Inc. (2004)

## Cited in the summary but kept off the family tree
- K051623: Anatomical Shoulder Keeled Glenoid, Zimmer GmbH (2005). Our reading of the summary gave K051623, FDA’s number for Anatomical Shoulder Keeled Glenoid (Zimmer GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Drager Evita XL”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K103803: Hamilton-G5 (2011), 14 descendants of its own

## Recalls of this device
- Apr 23, 2008 · Not classified · Z-1829-2008: There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer con
- Jul 2, 2007 · Not classified · Z-1526-2008: Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.

## Indications for use
The GE Datex-Ohmeda Engstr6m 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. Optional Neonatal capabilities expand the patient range to 0.5 kg. 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) Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG) 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/Wash Out method. Not all features are available with all patient populations. The Engstr6m 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/K062710
Methodology: https://510kreport.com/methodology