510(k) Report

Devices descending from K130531

7 later devices reach Ultrafuse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181225AltaporeBaxter Healthcare Corporation20186—
+2K192363AltaporeBaxter Healthcare Corporation20204—
+2K191513Altapore ShapeBaxter Healthcare Corporation20192—
+3K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+3K233259XerosynXerothera, Inc.20240—
+3K201464Altapore MISBaxter Healthcare Corporation20201—
+3K200640Altapore ShapeBaxter Healthcare Corporation20201—