# K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Mar 18, 2016 after 255 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: 5 generations back to K950680 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites 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)
- K150627: Rapid Aid Instant Disposable Infant Heel Warmer, Rapid Aid Corp. (2015) Summary page 4.
- K954716: Deroyal Industries Infant Heel Warmer, Debusk Knitting Mills, Div. Deroyal Industries (1996) Summary page 4.

## Most influential descendants
- K221154: Infant Heel WarmerTM; Heel Snuggler® (2022), 0 descendants of its own

## Indications for use
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. The device is primarily used in hospitals, doctor's offices, and other healthcare facilities.

Source page: https://510kreport.com/device/K151845
Methodology: https://510kreport.com/methodology