510(k) Report

Devices descending from K961154

5 later devices reach Baxter Sodium Acetate Infant Heel Warmer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032989Medi-Heat Infant Heel WarmerMediheat, Inc.20034—
+2K040856Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd.20043—
+3K150627Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp.20152—
+4K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc.20161—
+5K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical20220—