# K220742: NxtGen Infant Transport Incubator

- Pathway: 510(k) (Traditional)
- Applicant: International Biomedical
- Decided: Jul 15, 2022 after 123 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: 3 generations back to K854065 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103524: Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox, International Biomedical, Ltd. (2011) Summary page 4.

## Indications for use
The NextGen Transport Incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant’s status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.

Source page: https://510kreport.com/device/K220742
Methodology: https://510kreport.com/methodology