# K040910: Infant Incubator, Model CHS-I1000

- Pathway: 510(k) (Traditional)
- Applicant: Choong Wae Medical Corp.
- Decided: Apr 21, 2004 after 13 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 K974349 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974349: Ohmeda-Ohio Care Plus Incubator, Ohmeda Medical (1998) Summary page 1.

## Indications for use
The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHS-i1000 incubator is not for the transport of the patient. The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value. The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.

Source page: https://510kreport.com/device/K040910
Methodology: https://510kreport.com/methodology