510(k) Report

Devices descending from K091547

10 later devices reach Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20220—
+1K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20210—
+1K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.20180—
+1K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.20181—
+1K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation20162—
+1K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+1K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp.20100—
+2K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—
+2K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20200—
+2K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation20180—