# K140575: Engstrom Carestation, Engstrom Pro

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Feb 3, 2015 after 334 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: 13 generations back to K902859 (1991). 85 ancestors in all.
No later device cites it as a predicate yet.
8 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111116: Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000, Datex-Ohmeda (2011) Summary page 5.

## Indications for use
The GE Datex-Ohmeda Engström Carestation and Engström Pro are 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 on Engström Carestation and Engström Pro expand the patient range to 0.25 kg. The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry, and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory and an integrated air compressor. Options available on Engström Carestation only include integrated respiratory gas monitoring capabilities via various Datex- Ohmeda patient monitoring modules listed in the product labeling, 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 Engström 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/K140575
Methodology: https://510kreport.com/methodology