# K040856: Rapid Aid Instant Disposable Infant Heel Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Aid, Ltd.
- Decided: May 3, 2004 after 31 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
Longest line of descent: 3 generations back to K950680 (1995). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032989: Medi-Heat Infant Heel Warmer, Mediheat, Inc. (2003) Summary page 1.
- K936084: Omni Warm Gel Packs, Omni Therm, Inc. (1994) Summary page 1.
- K912715: Instant Warm Gel Pack, Prism Technologies, Inc. (1991) Summary page 1.

## Most influential descendants
- K150627: Rapid Aid Instant Disposable Infant Heel Warmer (2015), 2 descendants of its own
- 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

## Indications for use
Rapid Aid Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.

Source page: https://510kreport.com/device/K040856
Methodology: https://510kreport.com/methodology