# K053254: Infant Heel Warmer by Intco

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Intco Medical Supply Co., Ltd.
- Decided: Sep 19, 2006 after 302 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rapid Aid Infant Heel Warmer: named in the summary without a submission number

## Indications for use
The Infant Heel Warmer by Intco is a single use, non-toxic, non-sterile, disposable device. It is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis. Note: The device is to be limited to use in hospitals, doctor's offices, and other healthcare facilities that administer health care services to newborns and infants.

Source page: https://510kreport.com/device/K053254
Methodology: https://510kreport.com/methodology