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.
Clearance details
- Device name as filed
- Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
- Applicant
- Drägerwerk AG Co. Kgaa
- Product code
- 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.