# K121625: Lullaby TM Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Wipro GE Healthcare Private, Ltd.
- Decided: Sep 14, 2012 after 105 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 K963058 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963058: Infant Warmer System, Ohmeda Medical (1996) Summary page 1.

## Most influential descendants
- K173516: NuBorne Infant Warmer (2018), 0 descendants of its own

## Indications for use
Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used to facilitate the newborn's transition to the external environment or to provide a controlled open microenvironment.

Source page: https://510kreport.com/device/K121625
Methodology: https://510kreport.com/methodology