510(k) · Cleared
Recalled · Class I · 2024Perseus A500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical GmbH · BSZ Gas-Machine, Anesthesia
Cleared on Jun 20, 2014 as substantially equivalent to K042607 (Draeger Medical, Inc., 2004) and 2 other predicates after a 182-day review. Its family tree reaches back 6 generations to 1990. 3 of the 33 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Jun 20, 2014
- Review
- 182 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 3 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 6 generations to K901713 (1990). 30 ancestors in all, the oldest K900598 (1990). 2 later devices descend from it, 1 citing it directly. 3 of the 33 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 backK042607 Primus USDraeger Medical, Inc. · 2004 · Recalled
- This deviceK133886 Perseus A500Draeger Medical GmbH · 2014
- Descendant · cites it directly · 1 of its ownK230931 AtlanDrägerwerk AG Co. Kgaa · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 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 2 of 2 · See allView 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 | K042607 | Primus US | Draeger Medical, Inc. | 2004 | 2 |
| 0 (this device) | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | — |
| +1 | K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023 | Class I |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 1 |
| 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? (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 |
|---|---|---|---|
| * | K042607 | Primus USSummary page 5…ivalence: The Perseus A500 is substantial equivalent to the following predicate devices: 510(k) Number Trade or Proprietary or Model Name Manufacturer K042607 Primus US Draeger Medical GmbH K983635 JULIAN ANESTHESIA… | 2004 |
| * | K983635 | Julian Anesthesia Workstation, Model # JulianSummary page 5…s: 510(k) Number Trade or Proprietary or Model Name Manufacturer K042607 Primus US Draeger Medical GmbH K983635 JULIAN ANESTHESIA Draeger Medical GmbH __________WORKSTATION, MODEL #… | 1999 |
| * | K093633 | Infinity Acute Care System Workstation Critical CareSummary page 5…GmbH K983635 JULIAN ANESTHESIA Draeger Medical GmbH __________WORKSTATION, MODEL # JULIAN __________ K093633 Infinity Acute Care System Workstation Draeger Medical GmbH ______________ Critical Care… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230931 | Atlan Class I | 2023 | 1 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2024 | Class I | Z-1512-2024 | Labeling design | Unexpected shutdown while operating on battery power. |
| May 24, 2018 | Class II | Z-2254-2018 | 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… |
| Nov 12, 2015 | Class I | Z-0360-2016 | Nonconforming Material/Component | There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh… |
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 24 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230931 (Drägerwerk AG Co. Kgaa, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K042607.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 anesthesia workstation Perseus A500 Is Intended for use in anesthetizing adults, children, and neonates and can be used for automatic end manual ventilation, pressure- supported spontaneous breathing, and spontaneous breathing. Perseus A500 is equipped with airway monitoring, gas measurement and device moni- toring, 02 insufflation, and an anesthetic gas receiving system. Anesthesia is achieved through a mixture of pure oxygen and Air (medical…
Read the full statement (150 words)
The anesthesia workstation Perseus A500 Is Intended for use in anesthetizing adults,
children, and neonates and can be used for automatic end manual ventilation, pressure-
supported spontaneous breathing, and spontaneous breathing.
Perseus A500 is equipped with airway monitoring, gas measurement and device moni-
toring, 02 insufflation, and an anesthetic gas receiving system.
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 mask or an
endlotracheal tube.
The integrated breathing system can be used with partial rebreathing (low-flow or
minimum-flow).
A non-rebreathing system such as the Kuhn or Medec: Water System may be used at the
external fresh-gas outlet (optional).
Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accord-
ance with the intended use during surgical or diagnostic interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133886: Perseus A500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133886
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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