Babyleo TN500
by Draegerwerk AG & CO Kgaa 510(k)
Active
510(k) K162821
Overview
The Babyleo TN500 is a neonatal incubator and radiant warmer designed to provide thermoregulation for newborns and infants. It combines multiple heat sources to maintain optimal body temperature in open care, closed care, and transitional environments, ensuring stable thermal conditions for vulnerable patients.
This device is supplied as a reusable medical system intended for use in general hospital settings. It operates under FDA 510(k) clearance (K162821) and is classified as a Class II device. The Babyleo TN500 is engineered for clinical flexibility, allowing seamless transition between incubator and radiant warmer modes without disrupting patient warmth. Storage and maintenance requirements are specified in the manufacturer’s instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162821 | Date23 Jun 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5400
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Draegerwerk AG & Co. KGaA
Questions
What types of care environments is the Babyleo TN500 designed to support for newborns and infants?
The Babyleo TN500 is engineered to provide thermoregulation in multiple care settings, including open care, closed care, and transitional environments. Its dual functionality as both an incubator and a radiant warmer allows seamless transitions between modes without disrupting patient warmth, ensuring stable thermal conditions for vulnerable newborns and infants.
Is the Babyleo TN500 intended for single-use or reusable applications in a hospital setting?
The Babyleo TN500 is explicitly supplied as a reusable medical system, designed for use in general hospital settings. Maintenance and storage instructions are provided by the manufacturer to ensure proper care and longevity of the device.
How does the Babyleo TN500 differ from other neonatal incubators in terms of its regulatory pathway?
The Babyleo TN500 follows a traditional FDA 510(k) clearance pathway (K162821) and is classified as a Class II device. This regulatory route ensures it meets established safety and performance standards for neonatal incubators, with a focus on thermoregulation for newborns and infants in clinical environments.
What specific care settings or medical specialties is the Babyleo TN500 intended for according to its regulatory filings?
The device is categorized under the medical specialty description of 'General Hospital' and is intended for use in neonatal care settings where precise temperature control is critical. Its design supports environments requiring flexibility between incubator and radiant warmer modes, making it suitable for general neonatal units.