# K102227: Infa Warmer I

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Jan 21, 2011 after 165 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940951 (1995). 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)
- K060461: V-505 Infa Warmer, Atom Medical, Inc. (2006) Summary page 1.

## Indications for use
The Infat Warmer i is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Infat Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetrv and oxvgen density controlling.

Source page: https://510kreport.com/device/K102227
Methodology: https://510kreport.com/methodology