# K032989: Medi-Heat Infant Heel Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Mediheat, Inc.
- Decided: Oct 22, 2003 after 28 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: 2 generations back to K950680 (1995). 4 ancestors in all.
4 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)
- K912715: Instant Warm Gel Pack, Prism Technologies, Inc. (1991) Summary page 1.
- K936084: Omni Warm Gel Packs, Omni Therm, Inc. (1994) Summary page 1.
- K961154: Baxter Sodium Acetate Infant Heel Warmer, Baxter Healthcare Corp (1996) Summary page 1.
- (no number) DeRoyal Infant Heel Warmer: named in the summary without a submission number
- (no number) Tempra Heat Pack: named in the summary without a submission number

## Most influential descendants
- 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
- 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
MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities. Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses. The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.

Source page: https://510kreport.com/device/K032989
Methodology: https://510kreport.com/methodology