# K031096: Modification to Transport Incubator 185

- Pathway: 510(k) (Special)
- Applicant: International Biomedics, Inc.
- Decided: Jun 24, 2003 after 78 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 K850496 (1985). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850496: Transport Incubator 185, Airborne Life Support Systems, Inc. (1985) Summary page 3.

## Most influential descendants
- K103525: A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor Pulseox (2011), 0 descendants of its own
- K103523: 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor Pulseox (2011), 0 descendants of its own
- K081264: Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 (2009), 0 descendants of its own

## Indications for use
The “Transport Incubator 185A” 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. Intended use of the modified and predicate device (K850496A) are identical.

Source page: https://510kreport.com/device/K031096
Methodology: https://510kreport.com/methodology