# K103524: Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox

- Pathway: 510(k) (Special)
- Applicant: International Biomedical, Ltd.
- Decided: Apr 15, 2011 after 135 days
- Product code: FPL (Incubator, Neonatal Transport)
- Device class: 2
- Regulation: 21 CFR 880.5410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854065 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022876: Modification to Infant Life Support Module-20, International Biomedical, Inc. (2002) Summary page 1.

## Most influential descendants
- K220742: NxtGen Infant Transport Incubator (2022), 0 descendants of its own

## Indications for use
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.

Source page: https://510kreport.com/device/K103524
Methodology: https://510kreport.com/methodology