# K071142: GE Datex-Ohmeda Avance Anesthesia System

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Jun 6, 2007 after 43 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930017 (1994). 10 ancestors in all.
33 later devices descend from it; 2 cite it directly.
12 of 44 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.
- K061609: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K123125: GE Datex-Ohmeda Avance CS2 (2013), 11 descendants of its own
- K080175: Navigator Anesthesia Delivery System, Model 0998-00-3024-01 (2008), 11 descendants of its own

## 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/K071142
Methodology: https://510kreport.com/methodology