510(k) · Cleared
Recalled · 2010GE 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 Aug 29, 2008 as substantially equivalent to K071142 (Datex-Ohmeda, 2007) and 1 other predicate after a 60-day review. Its family tree reaches back 6 generations to 1994. 12 of the 43 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 29, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930017 (1994). 12 ancestors in all. 30 later devices descend from it, 3 citing it directly. 12 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 5 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 4 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 3 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- 2 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
- 1 generation backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
- This deviceK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008
- Descendant · cites it directly · 19 of its ownK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
- Descendant · cites it directly · 13 of its ownK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 9 of its ownK110213 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK102471 AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · Recalled (Class I)
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · cites it directly19descendants
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · cites it directly13descendants
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 2 generations on11descendants
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 2 generations on9descendants
- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −5 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −4 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −3 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| −2 | K061609 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2006 | 1 |
| −1 | K071142 | GE Datex-Ohmeda Avance Anesthesia System | Datex-Ohmeda | 2007 | — |
| 0 (this device) | K081844 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2008 | — |
| +1 | K090233 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2009 | 2 |
| +1 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| +2 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| +2 | K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2011 | Class I |
| +1 | K102471 | AS3700 Anesthsia Delivery System | Mindray DS USA, Inc. | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 3 |
| 2012 | 2 | 2 |
| 2013 | 5 | 1 |
| 2014 | 2 | 1 |
| 2015 | 3 | 0 |
| 2016 | 1 | 1 |
| 2017 | 3 | 1 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 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.
12 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 |
|---|---|---|---|
| * | K071142 | GE Datex-Ohmeda Avance Anesthesia SystemSummary page 3…OLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6) The GE Datex-Ohmeda Avance has been updated from the predicate version (K071 142). There have been no changes to the intended use or fundamental scientific technology. The software for the Avance has been updat… | 2007 |
| * | K073707 | GE Datex-Ohmeda AisysSummary page 1…substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Avance (KO71142) and the GE Datex-Ohmeda Aisys (K073707). 10… | 2008 |
| † | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories | 2000 |
| † | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using F-CU8 or… | 2006 |
| † | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | 2003 |
What descends from it? (30)
See all 303 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2010 | Not classified | Z-0009-2011 | Employee error | Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient… |
| Aug 30, 2010 | Not classified | Z-0010-2011 | Employee error | Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient… |
| Mar 12, 2010 | Not classified | Z-1527-2010 | Process design | Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and… |
| Feb 5, 2009 | Not classified | Z-1426-2009 | Component design/selection | Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds.… |
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.
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 2 generations on · ◆ 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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 19 Class I recalls
- K213867Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 14 Class I recalls
- K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090233 (Datex-Ohmeda, Inc., 2009) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K071142.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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. The device is intended for volume or pressure control ventilation. The Avance is not suitable for use in a MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081844: GE Datex-Ohmeda Avance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081844
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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