Babyleo TN500— 510(k) K251619
Substantially EquivalentDrägerwerk AG & Co. KGaA
FDA 510(k) clearance K251619 for Babyleo TN500, Substantially Equivalent on 2026-02-13. Applicant: Drägerwerk AG & Co. KGaA. Device class: 2.
Summary
Drägerwerk's Babyleo TN500 is filed under product code FMZ, neonatal incubator. The record doesn't describe it beyond the name and that code name.
Class II, 21 CFR 880.5400. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).
Drägerwerk filed from Luebeck, Germany. FDA found it substantially equivalent 262 calendar days after receipt (May 27, 2025 to February 13, 2026).
Clearance details
- Applicant
- Drägerwerk AG & Co. KGaA
- Product code
- Product code FMZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, DE
Recent devices under product code FMZ
view allMore clearances from Drägerwerk AG & Co. KGaA
view allAdverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
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.