# K112722: GE Datex-Ohmeda Avance

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Dec 16, 2011 after 88 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 5 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 83 ancestors in all.
13 later devices descend from it; 3 cite it directly.
11 of 97 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.
- K093886: Engstrom Carestation, Engstrom Pro, Datex-Ohmeda Inc., A Division of Instrumentarium C (2010) Summary page 1.

## Most influential descendants
- K123125: GE Datex-Ohmeda Avance CS2 (2013), 11 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own
- K131945: GE Datex-Ohmeda Avance CS2 (2013), 3 descendants of its own

## Recalls of this device
- Nov 3, 2016 · Class II · Z-0755-2017: GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer conta
- Dec 15, 2015 · Class II · Z-0681-2016: The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unr
- Sep 16, 2013 · Class I · Z-0009-2014: GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PC
- Aug 28, 2013 · Class I · Z-0010-2014: GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines.
- May 14, 2013 · Class II · Z-1443-2013: GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900,

## 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 (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Source page: https://510kreport.com/device/K112722
Methodology: https://510kreport.com/methodology