# K251619: Babyleo TN500

- Pathway: 510(k) (Traditional)
- Applicant: Drägerwerk AG & Co. KGaA
- Decided: Feb 13, 2026 after 262 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010222 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182859: Babyleo TN500, Dragerwerk AG & CO Kgaa (2019) Summary page 5.

## Indications for use
The Babyleo TN500 is intended for use with neonates and infants and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. It enables the controlled warming of patients with a body weight of up to 10 kg (22 lbs). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates and infants are kept warm in the patient compartment with humidifiable air which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. The Babyleo TN500 provides controlled ambient conditions for neonates and infants. The following parameters are regulated, according to the intended use: – Temperature – Humidity – Oxygen (option)

Source page: https://510kreport.com/device/K251619
Methodology: https://510kreport.com/methodology