# K042154: GE Datex-Ohmeda Aisys Carestation

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Aug 31, 2004 after 21 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930017 (1994). 8 ancestors in all.
36 later devices descend from it; 3 cite it directly.
12 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040743: Modification to Datex-Ohmeda S/5 Avance Anesthesia System, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K032803: Datex-Ohmeda S/5 Avance Anesthesia System, Datex-Ohmeda (2004) Summary page 1.
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu), Datex-Engstrom, Inc. (1998) Summary page 1.

## Most influential descendants
- K061609: GE Datex-Ohmeda Aisys (2006), 34 descendants of its own
- K071142: GE Datex-Ohmeda Avance Anesthesia System (2007), 33 descendants of its own
- K081844: GE Datex-Ohmeda Avance (2008), 30 descendants of its own
- K090233: GE Datex-Ohmeda Aisys (2009), 19 descendants of its own
- K112722: GE Datex-Ohmeda Avance (2011), 13 descendants of its own

## Recalls of this device
- Oct 30, 2008 · Not classified · Z-1633-2009: GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.
- Oct 30, 2008 · Not classified · Z-1635-2009: GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.
- Oct 30, 2008 · Not classified · Z-1634-2009: GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.

## Indications for use
The GE Datex-Ohmeda Aisys 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 ventilation. The Aisys Carestation is not suitable for use in a MRI environment.

Source page: https://510kreport.com/device/K042154
Methodology: https://510kreport.com/methodology