# K111116: Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Sep 9, 2011 after 141 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 84 ancestors in all.
3 later devices descend from it; 2 cite it directly.
9 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093886: Engstrom Carestation, Engstrom Pro, Datex-Ohmeda Inc., A Division of Instrumentarium C (2010) Summary page 2.
- K070513: Hamilton-G5, Hamilton Medical AG (2007) Summary page 2.

## Most influential descendants
- K142679: Carescape R860 (2015), 1 descendant of its own
- K210384: Carescape R860 (2021), 0 descendants of its own
- K140575: Engstrom Carestation, Engstrom Pro (2015), 0 descendants of its own

## Recalls of this device
- Apr 18, 2022 · Class I · Z-1227-2022: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- Apr 18, 2022 · Class I · Z-1226-2022: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- Jan 27, 2015 · Class II · Z-1270-2015: Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
- Aug 28, 2013 · Class I · Z-0010-2014: GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines.

## Indications for use
The GE Datex-Ohmeda Engström family of ventilators (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 family expand the patient range to 0.25 kg. The GE Datex-Ohmeda Engström 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 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/K111116
Methodology: https://510kreport.com/methodology