# K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer

- Pathway: 510(k) (Special)
- Applicant: Hill-Rom Air-Shields
- Decided: Nov 17, 2000 after 23 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.
18 later devices descend from it; 6 cite it directly.
6 of 19 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K070210: Giraffe and Panda  T- Piece Resuscitation System (2007), 10 descendants of its own
- K070247: Giraffe and Panda Bag and Mask Resuscitation System (2007), 4 descendants of its own
- K070377: Giraffe and Panda Warmer (2007), 3 descendants of its own
- K120642: Resuscitaire with Autobreath (2012), 2 descendants of its own
- K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) (2007), 2 descendants of its own

## Recalls of this device
- Jul 29, 2009 · Not classified · Z-1693-2009: Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

Source page: https://510kreport.com/device/K003335
Methodology: https://510kreport.com/methodology