# K170872: Aisys CS2

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Aug 15, 2017 after 145 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (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). 86 ancestors in all.
No later device cites it as a predicate yet.
7 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132530: GE Datex-Ohmeda Aisys CS2 (Aisys CS^2), Datex-Ohmeda, Inc. (2013) Summary page 4.

## 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
- Oct 4, 2017 · Class II · Z-1199-2018: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

## Indications for use
The Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide ride range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Source page: https://510kreport.com/device/K170872
Methodology: https://510kreport.com/methodology