# K964523: Recover Infant Heel Warmer (5100)

- Pathway: 510(k) (Traditional)
- Applicant: Florida Medical Industries, Inc.
- Decided: Feb 10, 1997 after 90 days
- Product code: MPO (Infant Heel Warmer (Chemical Heat Pack))
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: 4 (0 Class I)
- 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) Florida Medical Industries, Recover® Infant Heel Warmer: named in the summary without a submission number

## Recalls of this device
- Jun 9, 2021 · Class II · Z-2095-2021: A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the use
- Jun 9, 2021 · Class II · Z-2094-2021: A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the use
- Jul 31, 2015 · Class II · Z-2443-2015: Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
- Jul 31, 2015 · Class II · Z-2444-2015: Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

## Indications for use
The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant’s heel to ensure adequate blood for sampling.

Source page: https://510kreport.com/device/K964523
Methodology: https://510kreport.com/methodology