# K953489: Drager Infant Radiant Warmern RH600

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Feb 9, 1996 after 199 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K971198: Babytherm 8004 Babytherm 8010 (1997), 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

Source page: https://510kreport.com/device/K953489
Methodology: https://510kreport.com/methodology