510(k) Report

Devices descending from K033575

43 later devices reach One.Click Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080904Feel-Fine Insulin Pen NeedleFeel Tech2008307
+1K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd.200711—
+2K151090CPL Insulin Pen NeedleCpl Co., Ltd.20160—
+2K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.20160—
+2K152166JSM Insulin Pen NeedleJeesung Medical Co., Ltd.20160—
+2K152334Sungshim Insulin Pen NeedleSung Shim Medicare Co., Ltd.20160—
+2K152410Top Fine Pen NeedleMedexel Co.,Ltd20160—
+2K121632Comfort EZSimple Diagnostics, Inc.20121—
+2K120191Push-on Needle 30GX8MMScandinavian Health Limited20120—
+2K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd.201221—
+2K112789Easy TouchMhc Medical Products, LLC201102
+2K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109—
+3K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.20160—
+3K133100Carefine Pen NeedleFacet Technologies20143—
+3K120690Insulin Pen NeedleTiger Medical Products, Ltd.201220—
+3K113186Sterile Insulin Pen NeedleShina Corp.20124—
+4K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+4K152877SureFine Pen NeedleShina Med Corporation20161—
+4K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+4K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+4K133058Insulin Pen NeedleWenzhou Wuzhou Import & Export Co., Ltd.20140—
+4K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd.201418—
+5K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+5K250658SureFine Pen NeedleShina Med Corporation20250—
+5K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd.20183—
+5K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—
+5K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+5K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.20160—
+5K152824Medt Pen NeedleShandong Caremed Medical Products Co., Ltd.20162—
+6K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+6K221176Insulin Pen NeedleTianjin Huahong Technology Co., Ltd.20220—
+6K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Tianjin Huahong Technology Co., Ltd.20211—
+6K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+6K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+6K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+6K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+6K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+6K170846Disposable Insulin Pen NeedleJiangsu Caina Technology Co., Ltd.20171—
+7K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+7K230043Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+7K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+7K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—
+7K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—