510(k) Report

Devices descending from K162821

3 later devices reach Babyleo TN500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182859Babyleo TN500Dragerwerk AG & CO Kgaa20191—
+1K173516NuBorne Infant WarmerInternational Biomedical20180—
+2K251619Babyleo TN500Drägerwerk AG & Co. KGaA20260—