510(k) · Cleared
Recalled · Class I · 2019Datex-Ohmeda 7900 Ventilator Enhancements
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 7, 2003 as substantially equivalent to K960964 (Ohmeda Medical, 1996) and 3 other predicates after a 364-day review. Its family tree reaches back 1 generation to 1994. 44 of the 139 devices in its family, counting itself, have a Class I recall. 134 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Oct 7, 2003
- Review
- 364 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 3 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 1 generation to K930017 (1994). 4 ancestors in all. 134 later devices descend from it, 7 citing it directly. 44 of the 139 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- This deviceK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003
- Descendant · cites it directly · 107 of its ownK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- Descendant · 2 generations on · 57 of its ownK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- Descendant · 2 generations on · 49 of its ownK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
- Descendant · 3 generations on · 48 of its ownK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 47 of its ownK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 134 · See all- K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004 · cites it directly107descendants
- K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005 · 2 generations on57descendants
- K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005 · 2 generations on49descendants
- K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 3 generations on48descendants
- K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 3 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| 0 (this device) | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | — |
| +1 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| +2 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| +2 | K051895 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
| +3 | K060862 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 1 |
| +3 | K062710 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 1 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 2 |
| 2008 | 8 | 2 |
| 2009 | 8 | 2 |
| 2010 | 7 | 1 |
| 2011 | 13 | 7 |
| 2012 | 15 | 6 |
| 2013 | 10 | 4 |
| 2014 | 5 | 1 |
| 2015 | 7 | 1 |
| 2016 | 7 | 3 |
| 2017 | 7 | 4 |
| 2018 | 3 | 1 |
| 2019 | 6 | 3 |
| 2020 | 3 | 2 |
| 2021 | 5 | 2 |
| 2023 | 1 | 1 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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.
44 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K960964 | Ohmeda 7900 Anesthesia VentilatorSummary page 1…evices: 1. Ohmeda 7900 Anesthesia Ventilator - Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K960964 2. Ohmeda Excel 3000 Anesthesia Gas System - Class II - 21CFR868.5895, which has been the subject of… | 1996 |
| * | K973896 | Ohmeda Excel 3000 Anesthesia SystemSummary page 1…64 2. Ohmeda Excel 3000 Anesthesia Gas System - Class II - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K973896 3. Datex-Engstrom AS/3 Anesthesia Delivery Unit (ADU) - Class II - 21CFR868.5160, which has been the… | 1998 |
| * | K973985 | AS/3 Anaesthesia Delivery Unit (as/3 Adu)Summary page 1…3. Datex-Engstrom AS/3 Anesthesia Delivery Unit (ADU) - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with J?DA log number K973985 4. Puritan Bennett 7200 ICU Ventilator - Class IT - 21CFR868.5895, which has been the subject of a c… | 1998 |
| * | K930017 | PB 7200 Series Ventilatory System W/KeyboardSummary page 1…973985 4. Puritan Bennett 7200 ICU Ventilator - Class IT - 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K930017 This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestivd5 Anesthesia Systems.… | 1994 |
What descends from it? (134)
See all 1347 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041775 | GE Datex-Ohmeda Engstrom Carestation | 2004 | 107 |
| K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | 2004 | 38 |
| K050626 | GE Datex-Ohmeda Aespire 7900 Anesthesia System | 2005 | 4 |
| K042086 | Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | 2004 | 2 |
| K042419 | Fabius GS/Fabius Tiro Anesthesia System Class I | 2004 | 1 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire… Class I | 2017 | 0 |
| K051222 | AV-S Anaesthesia Ventilator | 2005 | 0 |
Has anything in its family been recalled? (44 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2019 | Class II | Z-0115-2020 | Software in the Use Environment | Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that… |
| Dec 15, 2015 | Class II | Z-0678-2016 | 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… |
| Apr 10, 2012 | Class I | Z-1787-2012 | Process control | GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent… |
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.
- 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
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 43 shown.
Nearest 5 of 43; all are on the web page.
What does this lineage say?
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda AestivdS Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient…
Read the full statement (199 words)
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda AestivdS Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered tot he patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Jntermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation. (optional).
This device is to be used only by trained and qualified medical professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K023366: Datex-Ohmeda 7900 Ventilator Enhancements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K023366
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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