# K081844: GE Datex-Ohmeda Avance

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Aug 29, 2008 after 60 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930017 (1994). 12 ancestors in all.
30 later devices descend from it; 3 cite it directly.
12 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071142: GE Datex-Ohmeda Avance Anesthesia System, Datex-Ohmeda (2007) Summary page 3.
- K073707: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2008) Summary page 1.

## Most influential descendants
- K090233: GE Datex-Ohmeda Aisys (2009), 19 descendants of its own
- K112722: GE Datex-Ohmeda Avance (2011), 13 descendants of its own
- K123125: GE Datex-Ohmeda Avance CS2 (2013), 11 descendants of its own
- K110213: GE Datex-Ohmeda Aisys (2011), 9 descendants of its own
- K102471: AS3700 Anesthsia Delivery System (2011), 9 descendants of its own

## Recalls of this device
- Aug 30, 2010 · Not classified · Z-0009-2011: 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
- Aug 30, 2010 · Not classified · Z-0010-2011: 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-1527-2010: 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
- Feb 5, 2009 · Not classified · Z-1426-2009: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message 

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

Source page: https://510kreport.com/device/K081844
Methodology: https://510kreport.com/methodology