# K040743: Modification to Datex-Ohmeda S/5 Avance Anesthesia System

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Apr 22, 2004 after 30 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: 2 generations back to K930017 (1994). 7 ancestors in all.
38 later devices descend from it; 3 cite it directly.
12 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032803: Datex-Ohmeda S/5 Avance Anesthesia System, Datex-Ohmeda (2004) Summary page 1.
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements, Datex-Ohmeda, Inc. (2003) Summary page 1.

## Most influential descendants
- K042154: GE Datex-Ohmeda Aisys Carestation (2004), 36 descendants of its own
- 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

## Indications for use
The Datex-Ohmeda S/5 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 S/5 Avance is not suitable for use in a MRI environment.

Source page: https://510kreport.com/device/K040743
Methodology: https://510kreport.com/methodology