510(k) · Cleared
Recalled · Class I · 2015Aespire 7900, Aespire View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · BSZ Gas-Machine, Anesthesia
Cleared on Oct 12, 2012 as substantially equivalent to K092864 (Datex-Ohmeda Inc., A Division of Instrumentarium C, 2010) after a 63-day review. Its family tree reaches back 9 generations to 1994. 3 of the 19 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- Oct 12, 2012
- Review
- 63 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930017 (1994). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 5 generations between
- 3 generations backK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
- 2 generations backK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
- 1 generation backK092864 Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- This deviceK122445 Aespire 7900, Aespire ViewDatex-Ohmeda · 2012
- Descendant · cites it directly · 1 of its ownK143530 Aespire ViewDatex-Ohmeda, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact…Datex-Ohmeda, Inc. · 2017 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 8 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 7 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 6 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- 5 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
- 4 generations backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
- 3 generations backK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
- 2 generations backK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
- 1 generation backK092864 Aespire 7900, Aespire ViewDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- This deviceK122445 Aespire 7900, Aespire ViewDatex-Ohmeda · 2012
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −8 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −7 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −6 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| −5 | K061609 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2006 | 1 |
| −4 | K071142 | GE Datex-Ohmeda Avance Anesthesia System | Datex-Ohmeda | 2007 | — |
| −3 | K081844 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2008 | 4 |
| −2 | K090233 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2009 | 2 |
| −1 | K092864 | Aespire 7900, Aespire View | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| 0 (this device) | K122445 | Aespire 7900, Aespire View | Datex-Ohmeda | 2012 | — |
| +1 | K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015 | 1 |
| +1 | 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 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K092864 | Aespire 7900, Aespire ViewSummary page 2…oducts are considered substantially equivalent to, and as safe and effective as, the legally marketed (predicate) GE Datex-Ohmeda Aespire 7900, Aespire View (K092864). DEVICE DESCRIPTION as required by 807.92(a)(4) The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 venti… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2015 | Class II | Z-0677-2016 | 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… |
| Feb 27, 2015 | Class II | Z-1376-2015 | Process control | Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation. |
| 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.
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- 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
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 10 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143530 (Datex-Ohmeda, Inc., 2015) has gone furthest, with 1 descendant 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. 2012, 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 family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122445: Aespire 7900, Aespire View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122445
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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