# K221154: Infant Heel WarmerTM; Heel Snuggler®

- Pathway: 510(k) (Traditional)
- Applicant: International Biomedical
- Decided: Oct 7, 2022 after 169 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: 6 generations back to K950680 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418), CooperSurgical, Inc. (2016) Summary page 4.

## Indications for use
The Infant Heel Warmer™,; Heel Snuggler® are instant warm packs 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, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™; Heel Snuggler® have two configurations, the Heel Snuggler®, which is designed to conform to the shape of the infant’s heel, and the standard Infant Heel Warmer™. The devices are primarily used in hospitals, Doctor’s offices, and other healthcare settings.

Source page: https://510kreport.com/device/K221154
Methodology: https://510kreport.com/methodology