FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Babyleo TN500
K Number: K251619
·
Decision Feb 13, 2026
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
3
Review Days
262
Basic Information
- Device Name
- Babyleo TN500
- K Number
- K251619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drägerwerk AG & Co. KGaA
- Date Received
- May 27, 2025
- Decision Date
- February 13, 2026
- Product Code
- FMZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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Other Clearances by Drägerwerk AG & Co. KGaA
| K Number | Device Name | ||
|---|---|---|---|
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Dec 1, 2025 | Substantially Equivalent |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Dec 7, 2022 | Substantially Equivalent |