# K970074: Stanilet Freestanding/CC Infant/2000C Infant Warmer (1250C/1500C/2000D)

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Apr 3, 1997 after 85 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 K942948 (1995). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942948: Stryker Powered Stretcher, Stryker Corp. (1995) Summary page 1.

## Most influential descendants
- K971366: Incuwarmer (1998), 2 descendants of its own
- 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 Stabilet~ Infant Radiant Warmer maintains the infant’s body temperature at a level determined by the caregiver through the use of an infrared radiant heating element and is designed to be used in those areas of the healthcare facility that provide neonatal and infant care.

Source page: https://510kreport.com/device/K970074
Methodology: https://510kreport.com/methodology