# K103527: Aviator Transport Incubator with Masimo Pulseox, Aviator 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: 1 generation back to K081399 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081399: Aviator Transport Incubator, International Biomedical, Ltd. (2008) Summary page 1.

## Most influential descendants
- K141565: Globe-Trotter GT5400 (2014), 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.

Source page: https://510kreport.com/device/K103527
Methodology: https://510kreport.com/methodology