510(k) Report

Devices descending from K150627

2 later devices reach Rapid Aid Instant Disposable Infant Heel Warmer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc.20161—
+2K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical20220—