510(k) · Cleared
Recalled · Class I · 2021Fabius Mri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. KG · BSZ Gas-Machine, Anesthesia
Cleared on Jul 30, 2008 as substantially equivalent to K042419 (Draeger Medical, Inc., 2004) and 1 other predicate after a 295-day review. Its family tree reaches back 7 generations to 1990. 3 of the 25 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times, including a Class I recall.
- Decided
- Jul 30, 2008
- Review
- 295 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 4 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 7 generations to K901713 (1990). 24 ancestors in all, the oldest K900598 (1990). No later device cites it as a predicate yet. 3 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 6 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 5 generations backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- 4 generations backK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- 3 generations backK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- 2 generations backK042086 Fabius GS Anesthesia System; Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004
- 1 generation backK042419 Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · Recalled (Class I)
- This deviceK072884 Fabius MriDraeger Medical AG & Co. KG · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −6 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −5 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| −4 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| −3 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| −2 | 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 |
| 0 (this device) | K072884 | Fabius Mri | Draeger Medical AG & Co. KG | 2008 | — |
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 |
| 2005 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K042419 | Fabius GS/Fabius Tiro Anesthesia SystemSummary page 1…sia (73 BSZ) Regulation Number: 21 CRF 868.5160 Class: II Predicate Device Identification: Fabius GS K042419 GE Datex Ohmeda Aestiva /5 MRI Anesthesia Sys… | 2004 |
| * | K050055 | GE Datex-Ohmeda Aestiva/5 Mri Anesthesia SystemSummary page 1…fication: Fabius GS K042419 GE Datex Ohmeda Aestiva /5 MRI Anesthesia System K050055 Section 3 - Page I of 3 510(k) Summary Fab… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2021 | Class II | Z-0501-2022 | Process control | 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate… |
| May 24, 2018 | Class II | Z-2252-2018 | 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-1481-2018 | 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. |
| Jun 22, 2015 | Class II | Z-2271-2015 | Labeling False and Misleading | the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI. |
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 18 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 24 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.
The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072884: Fabius Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072884
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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