# K243606: Babyroo TN300

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Jan 17, 2025 after 57 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- 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 K892885 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230278: Babyroo TN300, Draeger Medical Systems, Inc. (2023) Summary page 5.

## Indications for use
The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with patients with a body weight up to 10 kg (22 lb). The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

Source page: https://510kreport.com/device/K243606
Methodology: https://510kreport.com/methodology