510(k) Report

Devices descending from K080904

30 later devices reach Feel-Fine Insulin Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151090CPL Insulin Pen NeedleCpl Co., Ltd.20160—
+1K152166JSM Insulin Pen NeedleJeesung Medical Co., Ltd.20160—
+1K152334Sungshim Insulin Pen NeedleSung Shim Medicare Co., Ltd.20160—
+1K152410Top Fine Pen NeedleMedexel Co.,Ltd20160—
+1K121632Comfort EZSimple Diagnostics, Inc.20121—
+1K120191Push-on Needle 30GX8MMScandinavian Health Limited20120—
+1K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd.201221—
+1K112789Easy TouchMhc Medical Products, LLC201102
+2K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.20160—
+2K120690Insulin Pen NeedleTiger Medical Products, Ltd.201220—
+3K133058Insulin Pen NeedleWenzhou Wuzhou Import & Export Co., Ltd.20140—
+3K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd.201418—
+4K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd.20183—
+4K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+4K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.20160—
+4K152824Medt Pen NeedleShandong Caremed Medical Products Co., Ltd.20162—
+5K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+5K221176Insulin Pen NeedleTianjin Huahong Technology Co., Ltd.20220—
+5K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Tianjin Huahong Technology Co., Ltd.20211—
+5K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+5K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+5K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+5K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+5K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+5K170846Disposable Insulin Pen NeedleJiangsu Caina Technology Co., Ltd.20171—
+6K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+6K230043Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+6K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+6K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—
+6K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—