# K954716: Deroyal Industries Infant Heel Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Debusk Knitting Mills, Div. Deroyal Industries
- Decided: Jan 11, 1996 after 90 days
- Product code: MPO (Infant Heel Warmer (Chemical Heat Pack))
- Device class: 1
- Regulation: 21 CFR 890.5710
- 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; 2 cite 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (2016), 1 descendant of its own
- K221154: Infant Heel WarmerTM; Heel Snuggler® (2022), 0 descendants of its own
- K040044: Heel Snuggler, Model 99047 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K954716
Methodology: https://510kreport.com/methodology