# K120937: Sunflower Warner

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Jul 6, 2012 after 100 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: 1 generation back to K003335 (2000). 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)
- K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer, Hill-Rom Air-Shields (2000) Summary page 1.

## Indications for use
The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.

Source page: https://510kreport.com/device/K120937
Methodology: https://510kreport.com/methodology