# K103523: 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor Pulseox

- Pathway: 510(k) (Special)
- Applicant: International Biomedical, Ltd.
- Decided: May 11, 2011 after 161 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 K850496 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031096: Modification to Transport Incubator 185, International Biomedics, Inc. (2003) Summary page 1.

## Indications for use
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.

Source page: https://510kreport.com/device/K103523
Methodology: https://510kreport.com/methodology