# K913945: Stabilet Infant Radiant Warmer Model 2000C

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Feb 12, 1992 after 161 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020966: Rpi Replacement Heating Elements (2002), 0 descendants of its own

## Recalls of this device
- Jul 17, 2009 · Not classified · Z-1955-2009: Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.

Source page: https://510kreport.com/device/K913945
Methodology: https://510kreport.com/methodology