# K081399: Aviator Transport Incubator

- Pathway: 510(k) (Special)
- Applicant: International Biomedical, Ltd.
- Decided: Jun 6, 2008 after 18 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103527: Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox (2011), 1 descendant of its own
- K141565: Globe-Trotter GT5400 (2014), 0 descendants of its own

## Indications for use
The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.

Source page: https://510kreport.com/device/K081399
Methodology: https://510kreport.com/methodology