510(k) Report

Devices descending from K013782

4 later devices reach Disetronic Penfine Insulin Injection Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100436Clickfine Pen NeedleYpsomed AG20103—
+2K122969Clickfine Pen NeedleP/L Biomedical20122—
+3K131125Clickfine Pen NeedleYpsomed AG20131—
+4K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG20150—