Atlan (4 models)— 510(k) K252746
Substantially EquivalentDrägerwerk AG Co. Kgaa
FDA 510(k) clearance K252746 for Atlan (4 models), Substantially Equivalent on 2026-05-21. Applicant: Drägerwerk AG Co. Kgaa. Device class: 2.
Summary
Drägerwerk's record lists four Atlan entries: A100, A100 XL, A350 and A350 XL. The product code is BSZ, anesthesia gas machines.
Class II, 21 CFR 868.5160. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Dräger filed from Lübeck, Germany. The decision came 265 calendar days after receipt (August 29, 2025 to May 21, 2026).
Clearance details
- Device name as filed
- Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
- Applicant
- Drägerwerk AG Co. Kgaa
- Product code
- Product code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lübeck, DE
Recent devices under product code BSZ
view allMore clearances from Drägerwerk AG Co. Kgaa
view allAdverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.