Babyleo TN500— 510(k) K251619

Substantially Equivalent

Drägerwerk AG & Co. KGaA

FDA 510(k) clearance K251619 for Babyleo TN500, Substantially Equivalent on 2026-02-13. Applicant: Drägerwerk AG & Co. KGaA.

Clearance details

Applicant: Drägerwerk AG & Co. KGaA
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2025-05-27
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.