# K854065: Infant Life Support Module-20

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Biomedics, Inc.
- Decided: Jan 16, 1986 after 104 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022876: Modification to Infant Life Support Module-20 (2002), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K854065
Methodology: https://510kreport.com/methodology