# K022876: Modification to Infant Life Support Module-20

- Pathway: 510(k) (Special)
- Applicant: International Biomedical, Inc.
- Decided: Sep 11, 2002 after 12 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 K854065 (1986). 1 ancestor in all.
2 later devices descend 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)
- K854065: Infant Life Support Module-20, Intl. Biomedics, Inc. (1986) Summary page 3.

## Most influential descendants
- K103524: Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox (2011), 1 descendant of its own
- K220742: NxtGen Infant Transport Incubator (2022), 0 descendants of its own

## Indications for use
The “Infant Life Support Module - 20” 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 is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065)are identical.

Source page: https://510kreport.com/device/K022876
Methodology: https://510kreport.com/methodology