510(k) · Cleared
ClearedFabius GS Anesthesia System, Model Fabius GS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Feb 22, 2002 after a 290-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 18 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- Feb 22, 2002
- Review
- 290 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly. 4 of the 18 devices in this family, counting this one, have a Class I recall.
- This deviceK011404 Fabius GS Anesthesia System, Model Fabius GSDraeger Medical, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK030624 Modification to Fabius GS Anesthesia SystemDraeger Medical, Inc. · 2004
- Descendant · cites it directly · 15 of its ownK031400 Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2003
- Descendant · 2 generations on · 14 of its ownK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- Descendant · 3 generations on · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K030624Modification to Fabius GS Anesthesia SystemDraeger Medical, Inc. · 2004 · cites it directly15descendants
- K031400Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2003 · cites it directly15descendants
- K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on14descendants
- K042607Primus USDraeger Medical, Inc. · 2004 · 3 generations on10descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011404 | Fabius GS Anesthesia System, Model Fabius GS | Draeger Medical, Inc. | 2002 | — |
| +1 | K030624 | Modification to Fabius GS Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +1 | K031400 | Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2003 | — |
| +2 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +3 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| +4 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 1 |
| 2008 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 1 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K133886Perseus A500Draeger Medical GmbH · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K030624 (Draeger Medical, Inc., 2004) has gone furthest, with 15 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) | — |
https://510kreport.com/device/K011404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011404: Fabius GS Anesthesia System, Model Fabius GS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011404
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026