510(k) Report

Devices descending from K950680

9 later devices reach Infant Heel Warmer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982652Allegiance Porta-Warm MattressAllegiance Healthcare Corp.19992—
+1K961154Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp199651
+2K032989Medi-Heat Infant Heel WarmerMediheat, Inc.20034—
+2K021843Eyefeel Ophthalmic WarmerBio-Lipid, Inc.20021—
+3K082087Eyefeel Ophthalmic WarmerBio-Lipid, Inc.20080—
+3K040856Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd.20043—
+4K150627Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp.20152—
+5K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc.20161—
+6K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical20220—