# K190494: Infant Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo David Medical Device Co., Ltd.
- Decided: Nov 25, 2019 after 270 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- 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 K993407 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993407: Ohmeda Medical Omnibed, Ohmeda Medical (2000) Summary page 4.

## Indications for use
The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

Source page: https://510kreport.com/device/K190494
Methodology: https://510kreport.com/methodology