# K050676: GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Apr 12, 2005 after 27 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: 4 generations back to K930017 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042154: GE Datex-Ohmeda Aisys Carestation, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu), Datex-Engstrom, Inc. (1998) Summary page 1.

## Most influential descendants
- K090892: GE Datex-Ohmeda S/5 Adu Carestation (2009), 0 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 Anesthesia Delivery Unit 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/K050676
Methodology: https://510kreport.com/methodology