# K133886: Perseus A500

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical GmbH
- Decided: Jun 20, 2014 after 182 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K901713 (1990). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042607: Primus US, Draeger Medical, Inc. (2004) Summary page 5.
- K983635: Julian Anesthesia Workstation, Model # Julian, Draeger Medical, Inc. (1999) Summary page 5.
- K093633: Infinity Acute Care System Workstation Critical Care, Draegerwerk AG & CO Kgaa (2010) Summary page 5.

## Most influential descendants
- K230931: Atlan (2023), 1 descendant of its own
- K252746: Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL) (2026), 0 descendants of its own

## Recalls of this device
- Mar 20, 2024 · Class I · Z-1512-2024: Unexpected shutdown while operating on battery power.
- May 24, 2018 · Class II · Z-2254-2018: 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 t
- Nov 12, 2015 · Class I · Z-0360-2016: 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 oc

## Indications for use
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.

Source page: https://510kreport.com/device/K133886
Methodology: https://510kreport.com/methodology