# K033040: Phoenix Infant Radiant Warmer, Model 100NWS

- Pathway: 510(k) (Abbreviated)
- Applicant: International Hospital Supply Co.
- Decided: Dec 17, 2003 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant’s body temperature at a level determined by the caregiver by means of radiant heat. It is designed to be used in those areas of the health care facility that provide neonatal and infant care. Federal law restricts this device to sale or use by or upon the order of a licensed health care practitioner. Its use is restricted to health care facilities and only by persons with specific training and experience in the use of the device.

Source page: https://510kreport.com/device/K033040
Methodology: https://510kreport.com/methodology