510(k) · Cleared
Recalled · Class I · 2026Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Nov 3, 2017 as substantially equivalent to K023366 (Datex-Ohmeda, Inc., 2003) and 8 other predicates after a 120-day review. Its family tree reaches back 15 generations to 1991. 11 of the 94 devices in its family, counting itself, have a Class I recall. It has been recalled 23 times, including 10 Class I recalls.
- Decided
- Nov 3, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 23 (10 Class I)
- Predicates
- 9
Its longest line of descent runs back 15 generations to K902859 (1991). 93 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 11 of the 94 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations between
- 3 generations backK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 2 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 1 generation backK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
- This deviceK172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact…Datex-Ohmeda, Inc. · 2017
Show all 15 generations
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 14 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 13 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 12 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 11 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 10 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 9 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 8 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 7 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 5 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 4 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 3 generations backK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 2 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 1 generation backK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
- This deviceK172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact…Datex-Ohmeda, Inc. · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −14 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −13 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −12 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −11 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −10 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −9 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −8 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −7 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −5 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −4 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| −3 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| −2 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| −1 | K131945 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda | 2013 | 2 |
| 0 (this device) | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100… | Datex-Ohmeda, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 2 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 1 |
| 2004 | 8 | 1 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
11 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023366 | Datex-Ohmeda 7900 Ventilator EnhancementsSummary page 14…=== K172045 Product Code: BSZ Predicate Aestiva 7900 K023366 Devices: Aestiva MRI K050055 Aestiva 7100 Compact K000706 Aes… | 2003 |
| * | K050055 | GE Datex-Ohmeda Aestiva/5 Mri Anesthesia SystemSummary page 14…K172045 Product Code: BSZ Predicate Aestiva 7900 K023366 Devices: Aestiva MRI K050055 Aestiva 7100 Compact K000706 Aestiva 7100 K000706 Aes… | 2005 |
| * | K000706 | Datex-Ohmeda Aestiva/5 with 7100 VentilatorSummary page 14…ode: BSZ Predicate Aestiva 7900 K023366 Devices: Aestiva MRI K050055 Aestiva 7100 Compact K000706 Aestiva 7100 K000706 Aespire 100 K000706 Aes… | 2000 |
| * | K122445 | Aespire 7900, Aespire ViewSummary page 14…K000706 Aespire 100 K000706 Aespire 7100 K000706 Aespire 7900 K122445 Aespire View K143530 Avance K112722 Ava… | 2012 |
| * | K143530 | Aespire ViewSummary page 14…K000706 Aespire 7100 K000706 Aespire 7900 K122445 Aespire View K143530 Avance K112722 Avance CS2 K131945 Ais… | 2015 |
| * | K112722 | GE Datex-Ohmeda AvanceSummary page 14…K000706 Aespire 7900 K122445 Aespire View K143530 Avance K112722 Avance CS2 K131945 Aisys K110213 Ais… | 2011 |
| * | K131945 | GE Datex-Ohmeda Avance CS2Summary page 14…K122445 Aespire View K143530 Avance K112722 Avance CS2 K131945 Aisys K110213 Aisys CS2 K132530 Device The… | 2013 |
| * | K110213 | GE Datex-Ohmeda AisysSummary page 14…K143530 Avance K112722 Avance CS2 K131945 Aisys K110213 Aisys CS2 K132530 Device The GE Healthcare anesthesia machines are intended to provid… | 2011 |
| * | K132530 | GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Summary page 14…K112722 Avance CS2 K131945 Aisys K110213 Aisys CS2 K132530 Device The GE Healthcare anesthesia machines are intended to provide general Description: inhalation anesthesia and venti… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3190-2026 | Nonconforming Material/Component | 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 breathing system enabling continued… |
| Jul 30, 2026 | Class II | Z-3191-2026 | Nonconforming Material/Component | 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 breathing system enabling continued… |
| Jul 30, 2026 | Class II | Z-3192-2026 | Nonconforming Material/Component | 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 breathing system enabling continued… |
| Jul 30, 2026 | Class II | Z-3189-2026 | Nonconforming Material/Component | 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 breathing system enabling continued… |
| Jul 12, 2024 | Class I | Z-0074-2025 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Process control | There is a potential reversal of the O2 and air cylinder pressure transducer connections. |
| May 27, 2022 | Class II | Z-1427-2022 | Process control | 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 person. |
| Apr 25, 2022 | Class II | Z-1285-2022 | Under Investigation by firm | Backup batteries can fail earlier than their estimated life. |
| Apr 25, 2022 | Class II | Z-1286-2022 | Under Investigation by firm | Backup batteries can fail earlier than their estimated life. |
| Aug 2, 2021 | Class II | Z-2595-2021 | Under Investigation by firm | 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 over-delivery of volume to the patient. |
| Aug 2, 2021 | Class II | Z-2596-2021 | Under Investigation by firm | 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 over-delivery of volume to the patient. |
| Sep 17, 2020 | Class II | Z-0312-2021 | Process control | Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| Sep 17, 2020 | Class II | Z-0314-2021 | Process control | Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| Sep 17, 2020 | Class II | Z-0311-2021 | Process control | Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| Sep 17, 2020 | Class II | Z-0313-2021 | Process control | Flow sensors could have damaged tubes in the form of small punctures or cuts. |
The 5 latest of 23 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 7 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 36 of the 93 ancestors have a recall of any class; 10 have a Class I recall.
- 6 other devices also cite its predicate K023366.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
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…
Read the full statement (1,026 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172045: Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172045
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026