510(k) Report

Devices descending from K113332

16 later devices reach ON Call Chosen Lancing Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222656LDE4 Lancing DeviceI-Sens, Inc.20220—
+1K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation20221—
+1K221970Lancing deviceSteriLance Medical (Suzhou), Inc.20222—
+1K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T…Tianjin Huahong Technology Co., Ltd.20227—
+1K153670Genteel Lancing DeviceGenteel, LLC20163—
+2K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.20260—
+2K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.20250—
+2K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Tianjin Huahong Technology Co., Ltd.20243—
+2K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.20240—
+2K232330Lancing SystemNingbo Medsun Medical Co., Ltd.20240—
+2K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation20230—
+2K223643Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd.20230—
+2K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+3K262135Lancing deviceTianjin Huahong Technology Co., Ltd.20260—
+3K262211LancetTianjin Huahong Technology Co., Ltd.20260—
+3K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.20250—