510(k) Report

Devices descending from K112332

21 later devices reach Fine Ject Insulin Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120690Insulin Pen NeedleTiger Medical Products, Ltd.201220—
+2K133058Insulin Pen NeedleWenzhou Wuzhou Import & Export Co., Ltd.20140—
+2K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd.201418—
+3K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd.20183—
+3K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+3K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.20160—
+3K152824Medt Pen NeedleShandong Caremed Medical Products Co., Ltd.20162—
+4K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+4K221176Insulin Pen NeedleTianjin Huahong Technology Co., Ltd.20220—
+4K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Tianjin Huahong Technology Co., Ltd.20211—
+4K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+4K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+4K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+4K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+4K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+4K170846Disposable Insulin Pen NeedleJiangsu Caina Technology Co., Ltd.20171—
+5K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+5K230043Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+5K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+5K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—
+5K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—