Calculator, Drug Dose
FDA product code NDC · Class II (moderate risk) · 21 CFR 868.1890 · Anesthesiology
55510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Monarch Medical Technologies 6
- Voluntis Sa. 5
- Companion Medical, Inc. 4
- Glytec, LLC 3
- Sanofi, Inc. 2
- Welldoc, Inc. 2
- Glooko, Inc. 2
- Roche Diagnostics Corp. 2
- Medtronic Minimed 2
- Medical Decisions Network 1
- Medical Decision Network 1
- Dimensional Dosing Systems, Inc. 1
- Pronia Medical System, LLC 1
- Updoc, Inc. 1
- MD Scientific, LLC 1
- Collaborativemed, LLC 1
- The RX Files Corp. 1
- Retinalabs.Com 1
- Phase Medical, Inc. 1
- Pharmatrol, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254102 | GlucommanderNDC · Traditional | Glytec, LLC | 05/27/2026SE |
| K260910 | EndoTool IV Cloud 1.0NDC · Traditional | Glooko, Inc. | 05/01/2026SE |
| K253512 | MiniMed Go AppNDC · Traditional | Medtronic Minimed | 01/08/2026SE |
| K253281 | UpDocNDC · Traditional | Updoc, Inc. | 12/23/2025SE |
| K252104 | T1D1NDC · Traditional | Comerge AG | 08/20/2025SE |
| K241088 | EndoTool IV (3.1)NDC · Traditional | Monarch Medical Technologies | 12/11/2024SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | Medtronic Minimed | 11/12/2024SE |
| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
| K221924 | Digital RoutinesNDC · Traditional | Gnc Holdings, LLC | 03/15/2023SE |
| K211160 | EndoTool SubQ 2.1NDC · Traditional | Monarch Medical Technologies, LLC | 10/28/2021SE |
| K203434 | BlueStar RxNDC · Traditional | Welldoc, Inc. | 09/08/2021SE |
| K202596 | Insulia Diabetes Management CompanionNDC · Special | Voluntis Sa. | 06/04/2021SE |
| K201619 | EndoTool IV SystemNDC · Traditional | Monarch Medical Technologies, LLC | 08/07/2020SE |
| K201337 | InPen SystemNDC · Special | Companion Medical, Inc. | 06/18/2020SE |
| K200443 | EndoTool IV 1.10NDC · Traditional | Monarch Medical Technologies, LLC | 03/17/2020SE |
| K190487 | InPen Dose CalculatorNDC · Traditional | Companion Medical, Inc. | 02/18/2020SE |
| K192841 | InPen SystemNDC · Traditional | Companion Medical, Inc. | 02/10/2020SE |
| K181916 | d-Nav SystemNDC · Traditional | Hygieia, Inc. | 02/04/2019SE |
| K180366 | EndoTool SubQNDC · Traditional | Al Pacheco and Associates | 09/20/2018SE |
| K181327 | InPen Dose CalculatorNDC · Special | Companion Medical, Inc. | 07/06/2018SE |
| K171450 | Glooko Mobile Insulin Dosing SystemNDC · Traditional | Glooko, Inc. | 02/02/2018SE |
| K172177 | Insulia Diabetes Management CompanionNDC · Traditional | Voluntis Sa. | 11/07/2017SE |
| K163664 | Health-e-Connect System with IDANDC · Traditional | Alr Technologies | 09/18/2017SE |
| K152300 | GlucommanderNDC · Traditional | Glytec, LLC | 08/04/2017SE |
| K170669 | Insulia Diabetes Management CompanionNDC · Traditional | Voluntis Sa. | 06/19/2017SE |
| K160673 | Insulin Algorithms SystemNDC · Traditional | Insulin Algorithms | 06/07/2017SE |
| K171230 | My Dose CoachNDC · Special | Sanofi | 05/26/2017SE |
| K163099 | My Dose CoachNDC · Traditional | Sanofi, Inc. | 03/22/2017SE |
| K161865 | iSage Rx (iSage Rx Basal Insulin Titration)NDC · Traditional | Isag Rx, Inc. | 03/07/2017SE |
| K160949 | Go Dose SystemNDC · Traditional | Eli Lilly and Company | 12/22/2016SE |
| K161433 | Insulia Diabetes Management CompanionNDC · Traditional | Voluntis Sa. | 11/09/2016SE |
| K150910 | ACCU-CHEK Connect Diabetes Management AppNDC · Special | Roche Diabetes Care, Inc. | 06/03/2015SE |
| K142918 | EndoTool SubQNDC · Traditional | Monarch Medical Technologies | 04/24/2015SE |
| K141929 | Accu-Chek Connect Diabetes Management AppNDC · Traditional | Roche Diagnostics Corporation | 03/16/2015SE |
| K142123 | Reach Access Telemedicine Dose CalculatorNDC · Traditional | Reach Health, Inc. | 09/24/2014SE |
| K141321 | Glucostabilizer Insulin Dosing CalculatorNDC · Traditional | Medical Decision Network | 09/15/2014SE |
| K132547 | Endo Tool Glucose Management System (Egms)NDC · Abbreviated | Monarch Medical Technologies | 04/17/2014SE |
| K121542 | Picis Weight Based Dose ConverterNDC · Traditional | Picis, Inc. | 08/27/2012SE |
| K113853 | G+ SystemNDC · Traditional | Glytec, LLC | 05/08/2012SE |
| K101344 | G+ SystemNDC · Special | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 06/28/2010SE |
| K082512 | Intelligent Dosing System for Insulin-My Insulin DoserNDC · Traditional | Dimensional Dosing Systems, Inc. | 11/07/2008SE |
| K081388 | Glucocare Intensive Glycemic Control SystemNDC · Traditional | Pronia Medical System, LLC | 08/21/2008SE |
| K071713 | Clarian Glucose Stabilizer Insulin Dosing CalculatorNDC · Traditional | Medical Decisions Network | 10/12/2007SE |
| K053137 | Endotool Drug Dose CalculatorNDC · Traditional | MD Scientific, LLC | 06/14/2006SE |
| K061110 | Glucommander PlusNDC · Traditional | Collaborativemed, LLC | 06/07/2006SE |
| K043529 | Accu-Chek Advisor Insulin Guidance SoftwareNDC · Traditional | Roche Diagnostics Corp. | 04/08/2005SE |
| K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteNDC · Traditional | The RX Files Corp. | 08/09/2001SE |
| K000418 | PDT Dosecalculator, Model 80000NDC · Traditional | Retinalabs.Com | 10/24/2000SE |
| K884016 | DC-1 I.V. Dosage ComputerNDC · Traditional | Phase Medical, Inc. | 12/20/1988SE |
| K882001 | Diacare Monitoring SystemNDC · Traditional | Healthware Corp. | 10/18/1988SE |
| K864121 | Pharmacokinetics Software System (PPS)NDC · Traditional | Pharmatrol, Inc. | 12/10/1986SE |
| K854249 | Computer Assisted Diabetic IntructionNDC · Traditional | Applied Biomedical Computations, Inc. | 03/27/1986SE |
| K851573 | Abbott Pharamacokinetics SystemsNDC · Traditional | Abbott Laboratories | 01/08/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2778-2026 Class II | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or… | Medtronic MiniMed, Inc. | 06/16/2026Open, Classified |
| Z-0958-2026 Class II | InPen App, Model/CFN Number: MMT-8061 (Android Users)When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen… | Medtronic MiniMed, Inc. | 11/13/2025Open, Classified |
| Z-2496-2025 Class II | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that… | Medtronic MiniMed, Inc. | 06/16/2025Open, Classified |
| Z-0741-2023 Class II | InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA…Diabetes management app may crash immediately upon opening, while using the app and/or while app is running… | Companion Medical, Inc. | 11/08/2022Open, Classified |
| Z-0354-2020 Class II | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)Product was distributed prior to approval or clearance from FDA. | Monarch Medical Technologies | 10/01/2019Terminated |
| Z-2753-2019 Class II | Accu-Chek Connect Diabetes Management AppUsers with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. | Roche Diabetes Care, Inc. | 05/03/2019Terminated |
| Z-1786-2019 Class II | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and…Insulin dosing calculations were erroneously high. | Monarch Medical Technologies | 05/03/2019Open, Classified |
| Z-0478-2019 Class II | Insulia Diabetes Management CompanionThe firm identified an issue with the basal calculator identified on the Android version of the Insulia… | Voluntis | 10/08/2018Terminated |
| Z-0625-2018 Class II | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number…Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a… | Roche Diabetes Care, Inc. | 06/08/2017Terminated |
| Z-0197-2018 Class II | Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN…Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After… | Roche Diabetes Care, Inc. | 06/08/2017Terminated |
| Z-1899-2017 Class II | Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and…A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a… | Roche Diabetes Care, Inc. | 03/14/2017Terminated |
| Z-1099-2017 Class II | Accu-Chek Connect Diabetes Management AppiOS and Android: Under certain conditions the affected app versions may disregard historical bolus data… | Roche Diabetes Care, Inc. | 12/20/2016Terminated |
| Z-0586-2017 Class II | Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes… | Roche Diabetes Care, Inc. | 09/14/2016Terminated |