# K122445: Aespire 7900, Aespire View

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Oct 12, 2012 after 63 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K930017 (1994). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092864: Aespire 7900, Aespire View, Datex-Ohmeda Inc., A Division of Instrumentarium C (2010) Summary page 2.

## Most influential descendants
- 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
- Dec 15, 2015 · Class II · Z-0677-2016: 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
- Feb 27, 2015 · Class II · Z-1376-2015: Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation.
- 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 family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.

Source page: https://510kreport.com/device/K122445
Methodology: https://510kreport.com/methodology