510(k) · Cleared
Recalled · 2006GE 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 Jun 27, 2006 as substantially equivalent to K042154 (Datex-Ohmeda, Inc., 2004) after an 18-day review. Its family tree reaches back 4 generations to 1994. 12 of the 44 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930017 (1994). 9 ancestors in all. 34 later devices descend from it, 2 citing it directly. 12 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 3 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 2 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 1 generation backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- This deviceK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006
- Descendant · cites it directly · 33 of its ownK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
- Descendant · 2 generations on · 30 of its ownK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 19 of its ownK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 13 of its ownK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 11 of its ownK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007 · cites it directly33descendants
- K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · 2 generations on30descendants
- K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · 3 generations on19descendants
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 3 generations on13descendants
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −3 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −2 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −1 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| 0 (this device) | K061609 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2006 | — |
| +1 | K071142 | GE Datex-Ohmeda Avance Anesthesia System | Datex-Ohmeda | 2007 | — |
| +2 | K081844 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2008 | 4 |
| +3 | K090233 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2009 | 2 |
| +3 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| +4 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 3 |
| 2012 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K042154 | GE Datex-Ohmeda Aisys CarestationSummary page 1…ollowing currently marketed device: Datex-Ohmeda Aisys - Class 11 - 21CFR868.5 160, which has been the subject of a cleared 5 10O(k) with FDA log number K042 154 The GE Datex-Ohmeda Aisys Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide ran… | 2004 |
What descends from it? (34)
See all 342 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 10, 2006 | Not classified | Z-0021-2007 | Other | Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an… |
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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 3 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 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 4 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 19 Class I recalls
- K213867Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · 7 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 · 7 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 12 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K071142 (Datex-Ohmeda, 2007) has gone furthest, with 33 descendants of its own.
- 2 other devices also cite its predicate K042154.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aisys 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 Aisys is not suitable for use in a MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061609: GE Datex-Ohmeda Aisys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061609
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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