# K073707: GE Datex-Ohmeda Aisys

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jan 30, 2008 after 30 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
No predicates in its family tree.
31 later devices descend from it; 3 cite it directly.
11 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- 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
- K110213: GE Datex-Ohmeda Aisys (2011), 9 descendants of its own

## Recalls of this device
- Feb 5, 2009 · Not classified · Z-1425-2009: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message 
- Aug 28, 2008 · Not classified · Z-0020-2009: The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to ind

Source page: https://510kreport.com/device/K073707
Methodology: https://510kreport.com/methodology