# K141565: Globe-Trotter GT5400

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Sep 10, 2014 after 90 days
- Product code: FPL (Incubator, Neonatal Transport)
- Device class: 2
- Regulation: 21 CFR 880.5410
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081399 (2008). 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)
- K001019: TI500 Globe-Trotter Transport System, Hill-Rom Air-Shields (2000) Summary page 4.
- K103527: Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox, International Biomedical, Ltd. (2011) Summary page 4.

## Recalls of this device
- May 20, 2022 · Class II · Z-1365-2022: The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

## Indications for use
The Globe-Trotter GT5400 neonatal transport system is intended for the transport of newborns weighing up to 10 kg (22 lb) between healthcare facilities. It provides means to control air temperature, deliver oxygen, resuscitate, provide passive humidification, and ventilate with active humidification (optional). The Globe-Trotter GT5400 neonatal transport system is intended for use by trained health care professionals and is not intended for home use.

Source page: https://510kreport.com/device/K141565
Methodology: https://510kreport.com/methodology