510(k) · Cleared
Recalled · Class I · 2018Fabius GS/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 Oct 8, 2004 as substantially equivalent to K042086 (Draeger Medical, Inc., 2004) and 2 other predicates after a 31-day review. Its family tree reaches back 6 generations to 1990. 3 of the 24 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 11 times, including 4 Class I recalls.
- Decided
- Oct 8, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 11 (4 Class I)
- Predicates
- 3
Its longest line of descent runs back 6 generations to K901713 (1990). 22 ancestors in all, the oldest K900598 (1990). 1 later device descends from it, 1 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 5 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 4 generations backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- 3 generations backK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- 2 generations backK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- 1 generation backK042086 Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004
- This deviceK042419 Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK072884 Fabius MriDraeger Medical AG & Co. KG · 2008 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −5 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −4 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| −3 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| −2 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| −1 | K042086 | Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| 0 (this device) | K042419 | Fabius GS/Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K042086 | Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemSummary page 1…lvania 18969 USA Establishment Registration No.: 2517967 Devices to which substantial equivalence is claimed: Fabius GS/Fabius Tiro Anesthesia System - K042086 Evita 4 Continuous Ventilator - K961687 7900 Ventilator -… | 2004 |
| * | K961687 | EVITA 4Summary page 1…ich substantial equivalence is claimed: Fabius GS/Fabius Tiro Anesthesia System - K042086 Evita 4 Continuous Ventilator - K961687 7900 Ventilator - K023366 Device Description: The Fabius GS/Fabius Tiro is a continuous flow… | 1996 |
| * | K023366 | Datex-Ohmeda 7900 Ventilator EnhancementsSummary page 1…Fabius Tiro Anesthesia System - K042086 Evita 4 Continuous Ventilator - K961687 7900 Ventilator - K023366 Device Description: The Fabius GS/Fabius Tiro is a continuous flow gas anesthesia system. Intended Use: The Fabius GS/Fabius Tiro… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072884 | Fabius Mri Class I | 2008 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2018 | Class II | Z-2251-2018 | Process change control | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes… |
| May 24, 2018 | Class II | Z-2250-2018 | Process change control | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes… |
| Mar 1, 2018 | Class I | Z-1484-2018 | Process control | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail. |
| Mar 1, 2018 | Class I | Z-1482-2018 | Process control | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail. |
| Mar 1, 2018 | Class I | Z-1483-2018 | Process control | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail. |
| Aug 14, 2013 | Class I | Z-0008-2014 | Device Design | During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not… |
| Aug 26, 2010 | Not classified | Z-2479-2010 | Other | potential failures to Electri-Cord Manufacturing AC power cord |
| Aug 26, 2010 | Not classified | Z-2478-2010 | Other | potential failures to Electri-Cord Manufacturing AC power cord |
| Jul 7, 2008 | Not classified | Z-2338-2008 | Process control | The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable. |
| Feb 5, 2008 | Not classified | Z-1315-2008 | Nonconforming Material/Component | Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis. |
| Oct 3, 2006 | Not classified | Z-0048-2007 | Other | One of four casters may break loose from chassis |
The 5 latest of 11 recalls; the web page lists all.
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.
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 22 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K072884 (Draeger Medical AG & Co. KG, 2008) has gone furthest, with 0 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 Fabius GS/Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius GS/Fabius Tiro can be used for spontaneous, manually assisted, automatic, pressure support, or synchronized mandatory intermittent 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/K042419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042419: Fabius GS/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/K042419
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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