510(k) Report

Devices descending from K082820

9 later devices reach K-Pack II Needle - 29G Thin Wall through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222681Altaviz Needle KitAltaviz, LLC202211
+1K151398K-Pack II Needle - 29G x 5/16 Thin WallTerumo Europe N.V.20150—
+1K110850K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V.20115—
+2K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V.20250—
+2K231261Altaviz Needle Kit IIAltaviz, LLC20230—
+2K192057K-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—
+2K132233K-Pack II Needle - 27G X 3/4 Thin WallTerumo Europe N.V.20130—
+3K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.20231—
+4K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK20240—