510(k) · Cleared
Recalled · 2009GE Datex-Ohmeda Aisys
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 Jan 30, 2008 after a 30-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 30, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 2
- Predicates
- 0
31 later devices descend from it, 3 citing it directly. 11 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK073707 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2008
- Descendant · cites it directly · 30 of its ownK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
- Descendant · cites it directly · 19 of its ownK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 13 of its ownK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- Descendant · 3 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)
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · cites it directly30descendants
- K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · cites it directly19descendants
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 2 generations on13descendants
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 3 generations on11descendants
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073707 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2008 | — |
| +1 | K081844 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2008 | 4 |
| +1 | K090233 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2009 | 2 |
| +2 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| +3 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| +2 | K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (31)
See all 313 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 |
|---|---|---|---|---|
| Feb 5, 2009 | Not classified | Z-1425-2009 | 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.… |
| Aug 28, 2008 | Not classified | Z-0020-2009 | Manufacturing material removal | The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures. |
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.
- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 2 generations on · ◆ 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
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- 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
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 19 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
- K213867Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- Of its descendants, K081844 (Datex-Ohmeda, Inc., 2008) has gone furthest, with 30 descendants of its own.
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) | — |
https://510kreport.com/device/K073707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073707: GE Datex-Ohmeda Aisys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073707
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026