# K971366: Incuwarmer

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Jan 5, 1998 after 266 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 K942948 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940951: RW Resucitaire Infant Radiant Warmer, Air-Shields, Inc. (1995) Summary page 1.
- K960980: Isolette Infant Incubator, Air-Shields, Inc. (1996) Summary page 1.
- K943360: Ohio Care Plus Incubator, Ohmeda Medical (1994) Summary page 1.
- K970074: Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D), Hill-Rom, Inc. (1997) Summary page 1.

## Most influential descendants
- K993051: Versalet 7700 Care Center, Model # 7700 (2000), 1 descendant of its own
- K053399: Versalet 7700 Care Center (2006), 0 descendants of its own

## Indications for use
The IncuWarmer is a mobile,caster mounted, neonatal device which is used to assist in maintaining an infant’s skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in matemity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

Source page: https://510kreport.com/device/K971366
Methodology: https://510kreport.com/methodology