# K162821: Babyleo TN500

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: Jun 23, 2017 after 259 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: 1 generation back to K010222 (2001). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010222: Ohmeda Medical Giraffe Incubator, Ohmeda Medical (2001) Summary page 5.

## Most influential descendants
- K182859: Babyleo TN500 (2019), 1 descendant of its own
- K251619: Babyleo TN500 (2026), 0 descendants of its own
- K173516: NuBorne Infant Warmer (2018), 0 descendants of its own

## Indications for use
Babyleo TN500 is intended for use with premature babies and neonates 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. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 Ibs) and a height of up to 55 cm (22 in). 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 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. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

Source page: https://510kreport.com/device/K162821
Methodology: https://510kreport.com/methodology