510(k) Report

Devices descending from K151311

11 later devices reach Safe Block Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+1K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+2K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+2K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+2K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+2K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+2K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+2K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+3K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+3K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+3K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—