510(k) Report

Devices descending from K040814

16 later devices reach Modification to Precision Xtra Advanced Diabetes Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp.201010Class I
+1K080960Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models…Abbott Diabetes Care, Inc.20083—
+1K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsAbbott Diabetes Care, Inc.200601
+2K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20220—
+2K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.20210—
+2K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.20180—
+2K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.20181—
+2K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation20162—
+2K130094Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care20132—
+2K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+2K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp.20100—
+3K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation20220—
+3K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20200—
+3K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation20180—
+3K132511Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc.20131—
+4K153330FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20160—