510(k) · Cleared
ClearedAtlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)
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 May 21, 2026 as substantially equivalent to K230931 (Drägerwerk AG Co. Kgaa, 2023) after a 265-day review. Its family tree reaches back 8 generations to 1990. 3 of the 33 devices in its family, counting itself, have a Class I recall.
- Decided
- May 21, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K901713 (1990). 32 ancestors in all, the oldest K900598 (1990). No later device cites it as a predicate yet. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK901713 Narkomed 4 Anesthesia SystemDraeger Medical, Inc. · 1990
- 7 generations backK980553 Narkomed 6000 Model Number NM6000Draeger Medical, Inc. · 1998
- 6 generations backK993826 Narkomed 6000Draeger Medical, Inc. · 2000
- 5 generations backK033498 Narkomed 6400, Model NM6400Draeger Medical, Inc. · 2004 · Recalled
- 4 generations backK041622 Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia…Draeger Medical, Inc. · 2004
- 3 generations backK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- 2 generations backK133886 Perseus A500Draeger Medical GmbH · 2014 · Recalled (Class I)
- 1 generation backK230931 AtlanDrägerwerk AG Co. Kgaa · 2023 · Recalled (Class I)
- This deviceK252746 Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901713 | Narkomed 4 Anesthesia System | Draeger Medical, Inc. | 1990 | — |
| −7 | K980553 | Narkomed 6000 Model Number NM6000 | Draeger Medical, Inc. | 1998 | — |
| −6 | K993826 | Narkomed 6000 | Draeger Medical, Inc. | 2000 | — |
| −5 | K033498 | Narkomed 6400, Model NM6400 | Draeger Medical, Inc. | 2004 | 1 |
| −4 | K041622 | Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | Draeger Medical, Inc. | 2004 | — |
| −3 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| −2 | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | Class I |
| −1 | K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023 | Class I |
| 0 (this device) | 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 |
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.
What descends from it?
No later submission names this one as a predicate yet.
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.
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · Direct predicate · ◆ on the line of descent in FIG. 18 Class I recalls
- K133886Perseus A500Draeger Medical GmbH · 2014 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K093633Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 7 of the 32 ancestors have a recall of any class; 3 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. 2026, 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?
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: -…
Read the full statement (151 words)
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, N2O, and anesthetic gases
- O2 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).
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/K252746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252746: Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252746
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026