Clearance Summary
Babyleo TN500 received FDA 510(k) clearance under submission number K251619, sponsored by Drägerwerk AG & Co. KGaA. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-02-13.
- Submission: K251619
- Applicant / Sponsor: Drägerwerk AG & Co. KGaA
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 2026-02-13
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.