# K131945: GE Datex-Ohmeda Avance CS2

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Aug 8, 2013 after 42 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: 14 generations back to K902859 (1991). 85 ancestors in all.
3 later devices descend from it; 2 cite it directly.
11 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123125: GE Datex-Ohmeda Avance CS2, Datex-Ohmeda, Inc. (2013) Summary page 1.

## Most influential descendants
- K151570: Carestation 620/650/650C (2016), 1 descendant of its own
- K213867: Carestation 750/750c (2023), 0 descendants of its own
- K172045: Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 (2017), 0 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

## Indications for use
The GE Datex-Obmeda Avance CS2 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/K131945
Methodology: https://510kreport.com/methodology