510(k) Report

Devices descending from K110850

5 later devices reach K-Pack II Needle- 27G & 30G Thin Wall through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V.20250—
+1K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin…Terumo Europe N.V.20192—
+1K132233K-Pack II Needle - 27G X 3/4 Thin WallTerumo Europe N.V.20130—
+2K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.20231—
+3K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK20240—