# K252746: Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)

- Pathway: 510(k) (Traditional)
- Applicant: Drägerwerk AG Co. Kgaa
- Decided: May 21, 2026 after 265 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K901713 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230931: Atlan, Drägerwerk AG Co. Kgaa (2023) Summary page 5.

## Indications for 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, 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.

Source page: https://510kreport.com/device/K252746
Methodology: https://510kreport.com/methodology