# K110213: GE Datex-Ohmeda Aisys

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jul 20, 2011 after 176 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 9 (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). 84 ancestors in all.
9 later devices descend from it; 3 cite it directly.
8 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090233: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2009) Summary page 1.
- K093886: Engstrom Carestation, Engstrom Pro, Datex-Ohmeda Inc., A Division of Instrumentarium C (2010) Summary page 1.

## Most influential descendants
- 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
- K132530: GE Datex-Ohmeda Aisys CS2 (Aisys CS^2) (2013), 2 descendants of its own
- K201957: A8, A9 Anesthesia System (2021), 1 descendant of its own

## Recalls of this device
- Sep 27, 2018 · Class II · Z-0413-2019: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventil
- Sep 27, 2018 · Class II · Z-0411-2019: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventil
- Sep 27, 2018 · Class II · Z-0412-2019: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventil
- 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-1382-2016: 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-0680-2016: 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 Aisys 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. The Aisys is not suitable for use in a MRI environment.

Source page: https://510kreport.com/device/K110213
Methodology: https://510kreport.com/methodology