# K090892: GE Datex-Ohmeda S/5 Adu Carestation

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: Apr 30, 2009 after 30 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- 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: 8 generations back to K930017 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050676: GE Detax-Ohmeda Anesthesia Delivery Unit (Adu), Datex-Ohmeda, Inc. (2005) Summary page 1.
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu), Datex-Engstrom, Inc. (1998) Summary page 1.
- K090233: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2009) Summary page 1.
- K073707: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2008) Summary page 1.
- K061609: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2006) Summary page 1.
- K042154: GE Datex-Ohmeda Aisys Carestation, Datex-Ohmeda, Inc. (2004) Summary page 1.

## Recalls of this device
- May 14, 2013 · Class II · Z-1443-2013: GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900,

## Indications for use
The GE Datex-Ohmeda S/5 ADU Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.

Source page: https://510kreport.com/device/K090892
Methodology: https://510kreport.com/methodology