# K173516: NuBorne Infant Warmer

- Pathway: 510(k) (Abbreviated)
- Applicant: International Biomedical
- Decided: Aug 17, 2018 after 276 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 K963058 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121625: Lullaby TM Warmer, Wipro GE Healthcare Private, Ltd. (2012) Summary page 4.
- K162821: Babyleo TN500, Draegerwerk AG & CO Kgaa (2017) Summary page 4.

## Indications for use
The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother’s womb to the external environment. The device is intended to be used in a Labor & Delivery environment for warming the infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration thermoregulation therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/long duration warming therapy. The device allows access to the infants for various procedures, tilting of the mattress, weighing the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

Source page: https://510kreport.com/device/K173516
Methodology: https://510kreport.com/methodology