510(k) · Cleared
ClearedFabius GS Anesthesia System; Fabius 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 Aug 31, 2004 as substantially equivalent to K041622 (Draeger Medical, Inc., 2004) and 2 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1990. 3 of the 24 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Aug 31, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K901713 (1990). 21 ancestors in all, the oldest K900598 (1990). 2 later devices descend from it, 1 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 4 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 3 generations backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- 2 generations backK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- 1 generation backK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- This deviceK042086 Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK042419 Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK072884 Fabius MriDraeger Medical AG & Co. KG · 2008 · Recalled (Class I)
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 |
|---|---|---|---|---|---|
| −5 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −4 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −3 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| −2 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| −1 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| 0 (this device) | K042086 | Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +1 | K042419 | Fabius GS/Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | Class I |
| +2 | K072884 | Fabius Mri | Draeger Medical AG & Co. KG | 2008 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemSummary page 1…, Pennsylvania 18969 USA Establishment Registration No.: 2517967 Devices to which substantial equivalence is claimed: Fabius GS Anesthesia System - K041622 Fabius Tiro Anesthesia System - K041622 Evita 4 Conti… | 2004 |
| * | K961687 | EVITA 4Summary page 1…esia System - K041622 Fabius Tiro Anesthesia System - K041622 Evita 4 Continuous Ventilator - K961687 7900 Ventilator - K023366 Device Description: The Fabius GS and Fabius Tiro are continuous… | 1996 |
| * | K023366 | Datex-Ohmeda 7900 Ventilator EnhancementsSummary page 1…us Tiro Anesthesia System - K041622 Evita 4 Continuous Ventilator - K961687 7900 Ventilator - K023366 Device Description: The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems. Intended Use: The Fabius GS and Fa… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042419 | Fabius GS/Fabius Tiro Anesthesia System Class I | 2004 | 1 |
Has anything in its family been recalled? (3 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.
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- 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
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 5 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K042419 (Draeger Medical, Inc., 2004) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K041622.
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 GS and Fabius Tiro are indicated as a continuous flow anesthesia systems.
The Fabius GS and Fabius Tiro can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts these devices to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042086: Fabius GS Anesthesia System; Fabius Tiro Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042086
Report an extraction error
Are you the manufacturer?
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