# K950680: Infant Heel Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 23, 1995 after 190 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- K961154: Baxter Sodium Acetate Infant Heel Warmer (1996), 5 descendants of its own
- K032989: Medi-Heat Infant Heel Warmer (2003), 4 descendants of its own
- K040856: Rapid Aid Instant Disposable Infant Heel Warmer (2004), 3 descendants of its own
- K150627: Rapid Aid Instant Disposable Infant Heel Warmer (2015), 2 descendants of its own
- K982652: Allegiance Porta-Warm Mattress (1999), 2 descendants of its own

Source page: https://510kreport.com/device/K950680
Methodology: https://510kreport.com/methodology