# K090233: GE Datex-Ohmeda Aisys

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 5, 2009 after 34 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930017 (1994). 13 ancestors in all.
19 later devices descend from it; 5 cite it directly.
7 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081844: GE Datex-Ohmeda Avance, Datex-Ohmeda, Inc. (2008) Summary page 1.
- K073707: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K102182: Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 (2011), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own

## Recalls of this device
- Aug 30, 2010 · Not classified · Z-0008-2011: Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesi
- Mar 12, 2010 · Not classified · Z-1526-2010: Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventil

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

Source page: https://510kreport.com/device/K090233
Methodology: https://510kreport.com/methodology