510(k) Report

Devices descending from K022769

9 later devices reach Lifescan Onetouch Ultra Control Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.20174—
+1K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20122—
+1K103553Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionBionostics, Inc.20110—
+2K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Vivachek Laboratories, Inc.20183—
+2K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose…Tianjin Empecs Medical Device Co., Ltd.20170—
+2K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20140—
+3K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20231—
+3K223722MIO Blood Glucose Monitoring SystemMio Labs, Inc.20230—
+4K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.20250—