510(k) · Cleared
Recalled · 2005GE Datex-Ohmeda Aespire 7900 Anesthesia System
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 Mar 25, 2005 as substantially equivalent to K040743 (Datex-Ohmeda, Inc., 2004) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1994. 3 of the 13 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 25, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930017 (1994). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 2 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 1 generation backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- This deviceK050626 GE Datex-Ohmeda Aespire 7900 Anesthesia SystemDatex-Ohmeda, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK092864 Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- Descendant · 2 generations on · 2 of its ownK122445 Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK143530 Aespire ViewDatex-Ohmeda, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact…Datex-Ohmeda, Inc. · 2017 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K092864Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · cites it directly3descendants
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 2 generations on2descendants
- K143530Aespire ViewDatex-Ohmeda, Inc. · 2015 · 3 generations on1descendant
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −2 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −1 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| 0 (this device) | K050626 | GE Datex-Ohmeda Aespire 7900 Anesthesia System | Datex-Ohmeda, Inc. | 2005 | — |
| +1 | K092864 | Aespire 7900, Aespire View | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| +2 | K122445 | Aespire 7900, Aespire View | Datex-Ohmeda | 2012 | Class I |
| +3 | K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015 | 1 |
| +3 | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100… | Datex-Ohmeda, Inc. | 2017 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 1 | 1 |
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.
3 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 |
|---|---|---|---|
| * | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemSummary page 1…device: GE Datex-Ohmeda S/5 Avance Anesthesia System - Class fl - 21 CFR868.5160, which has been the subject of a cleared 5 10(k) with FDA log number K0040743 Datex-Ohmeda 7900 Ventilator Enhancements Class II - 21CFR868.5160, which has been the subject of a cleared 510(… | 2004 |
| * | K023366 | Datex-Ohmeda 7900 Ventilator EnhancementsSummary page 1…g number K0040743 Datex-Ohmeda 7900 Ventilator Enhancements Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K023366 The GE Datex-Ohmeda Aespire 7900 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092864 | Aespire 7900, Aespire View | 2010 | 3 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2005 | Not classified | Z-0038-06 | Other | Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen… |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 2 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
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 4 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K092864 (Datex-Ohmeda Inc., A Division of Instrumentarium C, 2010) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K040743.
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 Aespire 7900 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 modes. The Aespire 7900 is not suitable for use in a MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050626: GE Datex-Ohmeda Aespire 7900 Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050626
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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