510(k) Report

Devices descending from K151845

1 later device reach Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical20220—