510(k) · Cleared
Recalled · Class I · 2026Atlan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drägerwerk AG Co. Kgaa · BSZ Gas-Machine, Anesthesia
Cleared on Jul 23, 2023 as substantially equivalent to K133886 (Draeger Medical GmbH, 2014) after a 111-day review. Its family tree reaches back 7 generations to 1990. 3 of the 33 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 9 times, including 8 Class I recalls.
- Decided
- Jul 23, 2023
- Review
- 111 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 9 (8 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K901713 (1990). 31 ancestors in all, the oldest K900598 (1990). 1 later device descends from it, 1 citing it directly. 3 of the 33 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 backK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- 1 generation backK133886 Perseus A500Draeger Medical GmbH · 2014 · Recalled (Class I)
- This deviceK230931 AtlanDrägerwerk AG Co. Kgaa · 2023
- Descendant · cites it directly · 0 of its ownK252746 Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026 · cites it directly0descendants
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 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| −1 | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | Class I |
| 0 (this device) | K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023 | — |
| +1 | K252746 | Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K133886 | Perseus A500Summary page 4…Product code: BSZ Class: II Predicate Device: Perseus A500, K133886 Reference Devices: Dräger Primus US Apollo, K042607 Maquet Flow-I, K191027… | 2014 |
| † | K042607 | Primus US | 2004 |
| † | K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | 2020 |
| † | K170872 | Aisys CS2 | 2017 |
| † | K042419 | Fabius GS/Fabius Tiro Anesthesia System | 2004 |
| † | K011404 | Fabius GS Anesthesia System, Model Fabius GS | 2002 |
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 |
|---|---|---|---|
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL) | 2026 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2026 | Class I | Z-2208-2026 | Process change control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| May 7, 2026 | Class I | Z-2207-2026 | Process change control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Sep 9, 2025 | Class I | Z-2617-2025 | Process control | The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Sep 9, 2025 | Class I | Z-2616-2025 | Process control | The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Oct 15, 2024 | Class I | Z-0305-2025 | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Oct 15, 2024 | Class I | Z-0304-2025 | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Oct 15, 2024 | Class I | Z-0667-2025 | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Oct 15, 2024 | Class I | Z-0668-2025 | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Nov 17, 2023 | Class II | Z-0971-2024 | Use error | Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries. |
The 5 latest of 9 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 33 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K252746 (Drägerwerk AG Co. Kgaa, 2026) 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. 2023, 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?
Intended use This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions: — Ventilation monitoring — Inspiratory O2 measurement — Device monitoring — Anesthetic gas receiving system The following options are additionally…
Read the full statement (154 words)
Intended use
This device is intended for use in anesthetizing adults, pediatric patients, and
neonates. The device can be used for mechanical ventilation, manual ventilation,
pressure-supported spontaneous breathing, and spontaneous breathing.
The device is equipped with the following basic functions:
— Ventilation monitoring
— Inspiratory O2 measurement
— Device monitoring
— Anesthetic gas receiving system
The following options are additionally available:
— Patient-gas measurement module for O2, CO2, N20, and anesthetic gases
— 02 insufflation
Anesthesia is achieved through a mixture of pure oxygen and Air (medical
compressed air) or pure oxygen and nitrous oxide, with the addition of volatile
anesthetic agents.
Ventilation is accomplished on the patient through a laryngeal mask, a breathing
mask, or an endotracheal tube.
The integrated breathing system can be used with partial rebreathing (low-flow or
minimum-flow).
Indications
The device is specified for inhalational anesthesia and/or patient ventilation in
accordance with the intended use during surgical or diagnostic interventions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230931: Atlan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230931
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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