510(k) Report

Devices descending from K031200

7 later devices reach Modification to BD Ultra-Fine Iii Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143437Droplet Pen NeedlesHtl-Strefa S.A20154—
+1K070988SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)Shinchang Medical Co., Ltd.20070—
+1K050464Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2Ultimed, Inc.20050—
+2K171982Droplet Pen NeedleHtl-Strefa S.A20183—
+3K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.20260—
+3K230635Pen NeedleJiangsu Caina Medical Co.,Ltd20230—
+3K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd.20200—