FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K180366 |
Al Pacheco and Associates |
EndoTool SubQ |
09/20/2018 |
K163664 |
ALR TECHNOLOGIES |
Health-e-Connect System with IDA |
09/18/2017 |
K061110 |
COLLABORATIVEMED, LLC |
GLUCOMMANDER PLUS |
06/07/2006 |
K190487 |
Companion Medical, Inc. |
InPen Dose Calculator |
02/18/2020 |
K181327 |
Companion Medical, Inc. |
InPen Dose Calculator |
07/06/2018 |
K192841 |
Companion Medical, Inc. |
InPen System |
02/10/2020 |
K201337 |
Companion Medical, Inc. |
InPen System |
06/18/2020 |
K082512 |
DIMENSIONAL DOSING SYSTEMS, INC. |
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER |
11/07/2008 |
K160949 |
ELI LILLY AND COMPANY |
Go Dose System |
12/22/2016 |
K171450 |
Glooko, Inc |
Glooko Mobile Insulin Dosing System |
02/02/2018 |
K113853 |
GLYTEC, LLC |
G+ SYSTEM |
05/08/2012 |
K152300 |
GLYTEC, LLC |
Glucommander |
08/04/2017 |
K101344 |
GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) |
G+ SYSTEM |
06/28/2010 |
K221924 |
GNC Holdings, LLC |
Digital Routines |
03/15/2023 |
K181916 |
Hygieia, Inc |
d-Nav System |
02/04/2019 |
K160673 |
INSULIN ALGORITHMS |
Insulin Algorithms System |
06/07/2017 |
K161865 |
iSag Rx, Inc. |
iSage Rx (iSage Rx Basal Insulin Titration) |
03/07/2017 |
K053137 |
MD SCIENTIFIC LLC |
ENDOTOOL DRUG DOSE CALCULATOR |
06/14/2006 |
K141321 |
MEDICAL DECISION NETWORK |
GLUCOSTABILIZER INSULIN DOSING CALCULATOR |
09/15/2014 |
K071713 |
MEDICAL DECISIONS NETWORK |
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR |
10/12/2007 |
K132547 |
MONARCH MEDICAL TECHNOLOGIES |
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) |
04/17/2014 |
K142918 |
MONARCH MEDICAL TECHNOLOGIES |
EndoTool SubQ |
04/24/2015 |
K200443 |
Monarch Medical Technologies, LLC |
EndoTool IV 1.10 |
03/17/2020 |
K201619 |
Monarch Medical Technologies, LLC |
EndoTool IV System |
08/07/2020 |
K211160 |
Monarch Medical Technologies, LLC |
EndoTool SubQ 2.1 |
10/28/2021 |
K121542 |
PICIS INC. |
PICIS WEIGHT BASED DOSE CONVERTER |
08/27/2012 |
K081388 |
PRONIA MEDICAL SYSTEM, LLC |
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM |
08/21/2008 |
K142123 |
REACH HEALTH, INC. |
REACH ACCESS TELEMEDICINE DOSE CALCULATOR |
09/24/2014 |
K000418 |
RETINALABS.COM |
PDT DOSECALCULATOR, MODEL 80000 |
10/24/2000 |
K150910 |
ROCHE DIABETES CARE INC. |
ACCU-CHEK Connect Diabetes Management App |
06/03/2015 |
K141929 |
ROCHE DIAGNOSTICS CORPORATION |
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP |
03/16/2015 |
K171230 |
Sanofi |
My Dose Coach |
05/26/2017 |
K163099 |
Sanofi, Inc. |
My Dose Coach |
03/22/2017 |
K011571 |
THE RX FILES CORP. |
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE |
08/09/2001 |
K172177 |
Voluntis S.A. |
Insulia Diabetes Management Companion |
11/07/2017 |
K161433 |
VOLUNTIS S.A. |
Insulia Diabetes Management Companion |
11/09/2016 |
K170669 |
Voluntis S.A. |
Insulia Diabetes Management Companion |
06/19/2017 |
K202596 |
Voluntis, S.A. |
Insulia Diabetes Management Companion |
06/04/2021 |
K203434 |
WellDoc, Inc |
BlueStar Rx |
09/08/2021 |
K230813 |
Welldoc, Inc. |
BlueStar and BlueStar Rx |
07/28/2023 |