# K230931: Atlan

- Pathway: 510(k) (Traditional)
- Applicant: Drägerwerk AG Co. Kgaa
- Decided: Jul 23, 2023 after 111 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 9 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K901713 (1990). 31 ancestors in all.
1 later device descends 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)
- K133886: Perseus A500, Draeger Medical GmbH (2014) Summary page 4.

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

## Recalls of this device
- May 7, 2026 · Class I · Z-2208-2026: 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: 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: 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: 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: 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: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K230931
Methodology: https://510kreport.com/methodology