# K061609: GE Datex-Ohmeda Aisys

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 27, 2006 after 18 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930017 (1994). 9 ancestors in all.
34 later devices descend from it; 2 cite it directly.
12 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042154: GE Datex-Ohmeda Aisys Carestation, Datex-Ohmeda, Inc. (2004) Summary page 1.

## Most influential descendants
- K071142: GE Datex-Ohmeda Avance Anesthesia System (2007), 33 descendants of its own
- K081844: GE Datex-Ohmeda Avance (2008), 30 descendants of its own
- K090233: GE Datex-Ohmeda Aisys (2009), 19 descendants of its own
- K112722: GE Datex-Ohmeda Avance (2011), 13 descendants of its own
- K123125: GE Datex-Ohmeda Avance CS2 (2013), 11 descendants of its own

## Recalls of this device
- Aug 10, 2006 · Not classified · Z-0021-2007: Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appe

## Indications for use
The GE Datex-Ohmeda Aisys is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. 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/K061609
Methodology: https://510kreport.com/methodology