# K050626: GE Datex-Ohmeda Aespire 7900 Anesthesia System

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 25, 2005 after 14 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: 3 generations back to K930017 (1994). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040743: Modification to Datex-Ohmeda S/5 Avance Anesthesia System, Datex-Ohmeda, Inc. (2004) Summary page 1.
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements, Datex-Ohmeda, Inc. (2003) Summary page 1.

## Most influential descendants
- K092864: Aespire 7900, Aespire View (2010), 3 descendants of its own
- K122445: Aespire 7900, Aespire View (2012), 2 descendants of its own
- K143530: Aespire View (2015), 1 descendant of its own
- 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

## Recalls of this device
- Sep 27, 2005 · Not classified · Z-0038-06: Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may n

## Indications for use
The GE Datex-Ohmeda Aespire 7900 Anesthesia System 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 modes. The Aespire 7900 is not suitable for use in a MRI environment.

Source page: https://510kreport.com/device/K050626
Methodology: https://510kreport.com/methodology