FDA 510(k) Applications for Medical Device Product Code "NDC"
(Calculator, Drug Dose)
| 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 |
| K242066 | Amalgam Rx, Inc | iSage Rx | 08/21/2024 |
| 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 |
| K242775 | Medtronic MiniMed | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | 11/12/2024 |
| K132547 | MONARCH MEDICAL TECHNOLOGIES | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | 04/17/2014 |
| K241088 | Monarch Medical Technologies | EndoTool IV (3.1) | 12/11/2024 |
| 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 |
| K043529 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE | 04/08/2005 |
| 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 |
| K232451 | Voluntis SA. | Insulia Bolus Companion | 12/12/2023 |
| 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 |
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