# K132530: GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Dec 20, 2013 after 130 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K902859 (1991). 85 ancestors in all.
2 later devices descend from it; 2 cite it directly.
8 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110213: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K170872: Aisys CS2 (2017), 0 descendants of its own

## Recalls of this device
- Mar 15, 2016 · Class II · Z-1562-2016: The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway 
- Feb 17, 2016 · Class II · Z-1381-2016: GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia d
- 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-Ohmeda Aisys CS 2 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/K132530
Methodology: https://510kreport.com/methodology