510(k) · Cleared
Recalled · Class I · 2016GE Datex-Ohmeda Avance
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 Dec 16, 2011 as substantially equivalent to K081844 (Datex-Ohmeda, Inc., 2008) and 1 other predicate after an 88-day review. Its family tree reaches back 12 generations to 1991. 11 of the 97 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Dec 16, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 5 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 12 generations to K902859 (1991). 83 ancestors in all, the oldest K883038 (1988). 13 later devices descend from it, 3 citing it directly. 11 of the 97 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 1 generation backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- This deviceK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011
- Descendant · cites it directly · 11 of its ownK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 1 generation backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- This deviceK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · cites it directly11descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on4descendants
- K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 4 generations on3descendants
- K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −2 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −1 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| 0 (this device) | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | — |
| +1 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| +2 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| +4 | K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| +2 | K131945 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda | 2013 | 2 |
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 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 1 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K081844 | GE Datex-Ohmeda AvanceSummary page 1…7.92(a)(3) The GE Datex-Ohmeda Avance is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Avance (K081844) and GE Datex- Ohmeda Engstrom ventilator (K093886).… | 2008 |
| * | K093886 | Engstrom Carestation, Engstrom ProSummary page 1…lly equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Avance (K081844) and GE Datex- Ohmeda Engstrom ventilator (K093886). Page 2 of 4 DEVICE… | 2010 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2016 | Class II | Z-0755-2017 | Device Design | GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert… |
| Dec 15, 2015 | Class II | Z-0681-2016 | Nonconforming Material/Component | 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 unresolved, it could result in excessive… |
| Sep 16, 2013 | Class I | Z-0009-2014 | Software design | GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may… |
| Aug 28, 2013 | Class I | Z-0010-2014 | Nonconforming Material/Component | 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. As a result of a manufacturing issue… |
| May 14, 2013 | Class II | Z-1443-2013 | Component change control | 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, M904, 9300 systems. Reusable CO2… |
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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 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 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 19 Class I recalls
- K213867Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 83 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K123125 (Datex-Ohmeda, Inc., 2013) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K081844.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112722: GE Datex-Ohmeda Avance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112722
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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