# K172045: Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Nov 3, 2017 after 120 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 23 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 93 ancestors in all.
No later device cites it as a predicate yet.
11 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements, Datex-Ohmeda, Inc. (2003) Summary page 14.
- K050055: GE Datex-Ohmeda Aestiva/5 Mri Anesthesia System, Datex-Ohmeda, Inc. (2005) Summary page 14.
- K000706: Datex-Ohmeda Aestiva/5 with 7100 Ventilator, Datex-Ohmeda, Inc. (2000) Summary page 14.
- K122445: Aespire 7900, Aespire View, Datex-Ohmeda (2012) Summary page 14.
- K143530: Aespire View, Datex-Ohmeda, Inc. (2015) Summary page 14.
- K112722: GE Datex-Ohmeda Avance, Datex-Ohmeda, Inc. (2011) Summary page 14.
- K131945: GE Datex-Ohmeda Avance CS2, Datex-Ohmeda (2013) Summary page 14.
- K110213: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2011) Summary page 14.
- K132530: GE Datex-Ohmeda Aisys CS2 (Aisys CS^2), Datex-Ohmeda, Inc. (2013) Summary page 14.

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3190-2026: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathi
- Jul 30, 2026 · Class II · Z-3191-2026: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathi
- Jul 30, 2026 · Class II · Z-3192-2026: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathi
- Jul 30, 2026 · Class II · Z-3189-2026: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathi
- Jul 12, 2024 · Class I · Z-0074-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0077-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0076-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0075-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0080-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0081-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0082-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0084-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jul 12, 2024 · Class I · Z-0078-2025: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Jun 1, 2022 · Class I · Z-1389-2022: There is a potential reversal of the O2 and air cylinder pressure transducer connections.
- May 27, 2022 · Class II · Z-1427-2022: The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a perso
- Apr 25, 2022 · Class II · Z-1285-2022: Backup batteries can fail earlier than their estimated life.
- Apr 25, 2022 · Class II · Z-1286-2022: Backup batteries can fail earlier than their estimated life.
- Aug 2, 2021 · Class II · Z-2595-2021: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to ov
- Aug 2, 2021 · Class II · Z-2596-2021: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to ov
- Sep 17, 2020 · Class II · Z-0312-2021: Flow sensors could have damaged tubes in the form of small punctures or cuts.
- Sep 17, 2020 · Class II · Z-0314-2021: Flow sensors could have damaged tubes in the form of small punctures or cuts.
- Sep 17, 2020 · Class II · Z-0311-2021: Flow sensors could have damaged tubes in the form of small punctures or cuts.
- Sep 17, 2020 · Class II · Z-0313-2021: Flow sensors could have damaged tubes in the form of small punctures or cuts.

## Indications for use
The Aespire Anesthesia Gas System with 7100 Ventilator is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers give full control of the system configuration. It is available with up to three gases, two vaporizer positions and up to three cylinder connections. All models are available with O2/Air, O2/N2O, or O2/Air/N2O. All Aespire systems accept Tec series vaporizers. Safety features and devices within the Aespire with 7100 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The 7100 Ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator with a built in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. 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. The Aespire View 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. The Aestiva/5 Anesthesia Gas System with 7100 Ventilator is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers give full control of the system configuration. The Aestiva/5 with 7100 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Aestiva/5 with 7100 comes with up to two optional gases (air, CO2, heliox). All Aestiva systems accept Tec series vaporizers. Safety features and devices within the Aestiva/5 with 7100 decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The 7100 Ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator with a built in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation. (optional). This device is to be used only by trained and qualified medical professionals. The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment. The GE Datex-Ohmeda Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The GE Datex-Ohmeda Avance CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Source page: https://510kreport.com/device/K172045
Methodology: https://510kreport.com/methodology