510(k) · Cleared
Recalled · 2004Ohmeda Excel 3000 Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · BSZ Gas-Machine, Anesthesia
Cleared on Apr 21, 1998 after a 189-day review. The FDA summary names its predicate without a number. 44 of the 138 devices in its family, counting itself, have a Class I recall. 137 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 1998
- Review
- 189 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 1
- Predicates
- 0
137 later devices descend from it, 3 citing it directly. 44 of the 138 devices in this family, counting this one, have a Class I recall.
- This deviceK973896 Ohmeda Excel 3000 Anesthesia SystemOhmeda Medical · 1998
- Descendant · cites it directly · 134 of its ownK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 107 of its ownK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- Descendant · 3 generations on · 57 of its ownK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- Descendant · 3 generations on · 49 of its ownK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
- Descendant · 4 generations on · 48 of its ownK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 137 · See all- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · cites it directly134descendants
- K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004 · 2 generations on107descendants
- K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005 · 3 generations on57descendants
- K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005 · 3 generations on49descendants
- K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 4 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973896 | Ohmeda Excel 3000 Anesthesia System | Ohmeda Medical | 1998 | — |
| +1 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| +2 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| +3 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| +3 | K051895 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
| +4 | K060862 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2004 | 6 | 1 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 2 |
| 2008 | 9 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Ohmeda Excel Series Anesthesia Machines Named without a submission number | |
| * | — | Ohmeda APAC (Advanced Portable Anesthesia Care) System Named without a submission number | |
| * | — | Ohmeda 7900 Anesthesia Ventilator Named without a submission number |
What descends from it? (137)
See all 1373 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (44 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2004 | Not classified | Z-0967-04 | Other | Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System. |
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 · Cites it directly · ◆ in the 2003 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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 44 shown.
Nearest 5 of 44; all are on the web page.
What does this lineage say?
- Of its descendants, K023366 (Datex-Ohmeda, Inc., 2003) has gone furthest, with 134 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.
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 Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with…
Read the full statement (171 words)
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N20. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxnc mixtures, ‘agent mixtures and.complete power or sudden gas supply-failures.- -
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973896: Ohmeda Excel 3000 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/K973896
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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