# K031387: Isolette Infant Incubator, Model C2000E

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Manufacturing, Inc.
- Decided: Aug 1, 2003 after 91 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 K960980 (1996). 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)
- K960980: Isolette Infant Incubator, Air-Shields, Inc. (1996) Summary page 1.

## Indications for use
The Air Shields ISOLETTE@Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator. It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE@to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, Ill, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics. This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment. This device is not intended for home use.

Source page: https://510kreport.com/device/K031387
Methodology: https://510kreport.com/methodology