# K093886: Engstrom Carestation, Engstrom Pro

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda Inc., A Division of Instrumentarium C
- Decided: May 3, 2010 after 136 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: 11 generations back to K902859 (1991). 75 ancestors in all.
21 later devices descend from it; 3 cite it directly.
14 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081842: Engstrom Carestation, Engstrom Pro, Datex-Ohmeda, Inc. (2008) Summary page 1.
- K063404: Servo-I Ventilator System, Models 64, 87 and 800, Maquet Critical Care AB (2007) Summary page 1.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.
- K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 1.

## Most influential descendants
- K112722: GE Datex-Ohmeda Avance (2011), 13 descendants of its own
- K123125: GE Datex-Ohmeda Avance CS2 (2013), 11 descendants of its own
- K110213: GE Datex-Ohmeda Aisys (2011), 9 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own

## Indications for use
The GE Datex-Ohmeda Engstrøm family of ventilators (Engstrøm Carestation and Engstrøm 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 Engstrøm family expand the patient range to 0.25 kg. The GE Datex-Ohmeda Engstrøm family of ventilators 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 Engstrøm 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 Engstrøm 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/K093886
Methodology: https://510kreport.com/methodology