Atlan A350 XL
Available with either electronically or mechanically controlled gas mixer variant
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Prunus Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | BSZ |
| Device type | Gas-Machine, Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5160 |
| 510(k) | K230931 |
| Record published | 2023-09-21 |
| Record revised | 2025-06-04 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8621600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A9800 Anesthesia Workstation | Oricare Inc. | 22 |
| Analgesia GAS Mixer, Digital MDM Delivery System | Parker Hannifin Corp. | 12 |
| Aladin2 | Datex-Ohmeda, Inc. | 12 |
| Penlon | Penlon Ltd. | 7 |
| Analgesia GAS Mixer, MDM Delivery System | Parker Hannifin Corp. | 6 |
| Codonics SLS500i Operating Software | Codonics, Inc. | 4 |
| Codonics Safe Label System®(SLS) 500i Point of Care Station | Codonics, Inc. | 4 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 4 |
| Codonics Safe Label System®(SLS) 550i Point of Care Station – 144C | Codonics, Inc. | 3 |
| Aestiva | Datex-Ohmeda, Inc. | 2 |
| Aisys | Datex-Ohmeda, Inc. | 2 |
| Infinium Medical Inc. | Infinium Medical, Inc. | 2 |
Showing 12 of 293. All products under Gas-Machine, Anesthesia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252746 | 2026-05-21 |
| K230931 | 2023-07-23 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2026-05-07 | Class I | Process change control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 3,515 units |
| Draeger, Inc. | 510(k) number | 2026-05-07 | Class I | Process change control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 394 units |
| Draeger, Inc. | 510(k) number | 2025-09-09 | Class I | Process control | The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 530 |
| Draeger, Inc. | 510(k) number | 2025-09-09 | Class I | Process control | The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 223 |
| Draeger, Inc. | 510(k) number | 2024-10-15 | Class I | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 1,492 units (139 units US, 1,353 OUS) |
| Draeger, Inc. | 510(k) number | 2024-10-15 | Class I | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 455 units (310 units US, 145 OUS) |
| Draeger, Inc. | 510(k) number | 2024-10-15 | Class I | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 280 units (OUS only) |
| Draeger, Inc. | 510(k) number | 2024-10-15 | Class I | Process control | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | 25 units (OUS Only) |
| Draegerwerk AG & Co. KGaA | 510(k) number | 2023-11-17 | Class II | Use error | 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. | 50 imported to US, not distributed to end users |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.