510(k) Report

Devices descending from K090057

17 later devices reach ON-Call Plus Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113332ON Call Chosen Lancing DeviceACON Laboratories, Inc.201216—
+2K222656LDE4 Lancing DeviceI-Sens, Inc.20220—
+2K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation20221—
+2K221970Lancing deviceSteriLance Medical (Suzhou), Inc.20222—
+2K220475Lancet (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—
+2K153670Genteel Lancing DeviceGenteel, LLC20163—
+3K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.20260—
+3K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.20250—
+3K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Tianjin Huahong Technology Co., Ltd.20243—
+3K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.20240—
+3K232330Lancing SystemNingbo Medsun Medical Co., Ltd.20240—
+3K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation20230—
+3K223643Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd.20230—
+3K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+4K262135Lancing deviceTianjin Huahong Technology Co., Ltd.20260—
+4K262211LancetTianjin Huahong Technology Co., Ltd.20260—
+4K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.20250—