510(k) · Cleared
ClearedFabius Tiro Anesthesia System
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 Jul 15, 2003 as substantially equivalent to K011404 (Draeger Medical, Inc., 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 2000. 4 of the 18 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Jul 15, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000859 (2000). 2 ancestors in all. 15 later devices descend from it, 1 citing it directly. 4 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK000859 Office Based Anesthesia Machine, Model Oba-1Charles A. Smith · 2000
- This deviceK031400 Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- Descendant · 2 generations on · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K041622Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · cites it directly14descendants
- K042607Primus USDraeger Medical, Inc. · 2004 · 2 generations on10descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on4descendants
- K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000859 | Office Based Anesthesia Machine, Model Oba-1 | Charles A. Smith | 2000 | — |
| 0 (this device) | K031400 | Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2003 | — |
| +1 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +2 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| +3 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| +4 | K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 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), 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.
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? (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 |
|---|---|---|---|
| * | K011404 | Fabius GS Anesthesia System, Model Fabius GS | 2002 |
| * | K000859 | Office Based Anesthesia Machine, Model Oba-1Summary page 2…. The tethered yoke assembly is similar to the oxygen manifold for one e-cylinder and pipeline supply offered by OBAMED Inc. for the OBA-1 Anesthesia Unit (K000859) in that both contain a yoke assembly, regulator, cylinder contents gauge, and a connecting hose. The manifold and… | 2000 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | 2004 | 14 |
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 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K133886Perseus A500Draeger Medical GmbH · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
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 Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031400: Fabius Tiro 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/K031400
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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