510(k) · Cleared
ClearedModification to Fabius 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 Jul 8, 2004 as substantially equivalent to K030624 (Draeger Medical, Inc., 2004) and 2 other predicates after a 22-day review. Its family tree reaches back 4 generations to 1990. 4 of the 30 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Jul 8, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K901713 (1990). 15 ancestors in all, the oldest K900598 (1990). 14 later devices descend from it, 2 citing it directly. 4 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 3 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 2 generations backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- 1 generation backK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- This deviceK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK133886 Perseus A500Draeger Medical GmbH · 2014 · Recalled (Class I)
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K042607Primus USDraeger Medical, Inc. · 2004 · cites it directly10descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on4descendants
- K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 3 generations on3descendants
- K133886Perseus A500Draeger Medical GmbH · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −3 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −2 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| −1 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| 0 (this device) | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| +1 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| +2 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| +3 | K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| +2 | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | 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 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 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? (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 |
|---|---|---|---|
| * | K030624 | Modification to Fabius GS Anesthesia SystemSummary page 1…elford, Pennsylvania 18969 USA Establishment Registration No.: 2517967 Devices to which substantial equivalence is claimed: Fabius GS Anesthesia System - K030624 Fabius Tiro Anesthesia System - K03 1400 Narkomed 6400 An… | 2004 |
| * | K031400 | Fabius Tiro Anesthesia SystemSummary page 1…evices to which substantial equivalence is claimed: Fabius GS Anesthesia System - K030624 Fabius Tiro Anesthesia System - K03 1400 Narkomed 6400 Anesthesia System - K033498 Device Description: The Fabius GS and Fabius Tiro a… | 2003 |
| * | K033498 | Narkomed 6400, Model NM6400Summary page 1…hesia System - K030624 Fabius Tiro Anesthesia System - K03 1400 Narkomed 6400 Anesthesia System - K033498 Device Description: The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems. Intended Use: The Fabius GS may be… | 2004 |
What descends from it? (14)
See all 142 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 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K133886Perseus A500Draeger Medical GmbH · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K042607 (Draeger Medical, Inc., 2004) has gone furthest, with 10 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 is indicated as a continuous flow anesthesia system. The Fabius GS 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 this device to sale by or on the order of a physician. The Fabius Tiro is indicated as a continuous flow…
Read the full statement (118 words)
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS 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 this device to sale by or on the order of a physician.
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/K041622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041622: Modification to 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 5, 2026. https://510kreport.com/device/K041622
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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