510(k) Report

Devices descending from K140516

4 later devices reach Terumo Pen Injector Needle 34 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250700Pen Injector Needle 32.5Terumo Corporation20250—
+1K192082Droplet Pen Needle 34GHtl-Strefa S.A20202—
+2K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+2K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—