# K102279: INCU I

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Dec 29, 2010 after 140 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: 4 generations back to K962603 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061856: V-2200 Infant Incubator, Atom Medical, Inc. (2006) Summary page 2.
- K003067: CALEO, Drager Medizintechnik GmbH (2000) Summary page 2.

## Indications for use
The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry, and oxygen density controlling.

Source page: https://510kreport.com/device/K102279
Methodology: https://510kreport.com/methodology