510(k) Report

Devices descending from K143437

4 later devices reach Droplet Pen Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171982Droplet Pen NeedleHtl-Strefa S.A20183—
+2K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.20260—
+2K230635Pen NeedleJiangsu Caina Medical Co.,Ltd20230—
+2K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd.20200—