510(k) Report

Devices descending from K113186

4 later devices reach Sterile Insulin Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+1K152877SureFine Pen NeedleShina Med Corporation20161—
+2K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+2K250658SureFine Pen NeedleShina Med Corporation20250—