| Glucommander (K254102) | Glytec, LLC | 2026-05-27 |
| EndoTool IV Cloud 1.0 (K260910) | Glooko, Inc. | 2026-05-01 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| UpDoc (K253281) | Updoc, Inc. | 2025-12-23 |
| T1D1 (K252104) | Comerge AG | 2025-08-20 |
| EndoTool IV (3.1) (K241088) | Monarch Medical Technologies | 2024-12-11 |
| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| iSage Rx (K242066) | Amalgam Rx, Inc. | 2024-08-21 |
| Insulia Bolus Companion (K232451) | Voluntis Sa. | 2023-12-12 |
| BlueStar and BlueStar Rx (K230813) | Welldoc, Inc. | 2023-07-28 |
| Digital Routines (K221924) | Gnc Holdings, LLC | 2023-03-15 |
| EndoTool SubQ 2.1 (K211160) | Monarch Medical Technologies, LLC | 2021-10-28 |
| BlueStar Rx (K203434) | Welldoc, Inc. | 2021-09-08 |
| Insulia Diabetes Management Companion (K202596) | Voluntis Sa. | 2021-06-04 |
| EndoTool IV System (K201619) | Monarch Medical Technologies, LLC | 2020-08-07 |
| InPen System (K201337) | Companion Medical, Inc. | 2020-06-18 |
| EndoTool IV 1.10 (K200443) | Monarch Medical Technologies, LLC | 2020-03-17 |
| InPen Dose Calculator (K190487) | Companion Medical, Inc. | 2020-02-18 |
| InPen System (K192841) | Companion Medical, Inc. | 2020-02-10 |
| d-Nav System (K181916) | Hygieia, Inc. | 2019-02-04 |
| EndoTool SubQ (K180366) | Al Pacheco and Associates | 2018-09-20 |
| InPen Dose Calculator (K181327) | Companion Medical, Inc. | 2018-07-06 |
| Glooko Mobile Insulin Dosing System (K171450) | Glooko, Inc. | 2018-02-02 |
| Insulia Diabetes Management Companion (K172177) | Voluntis Sa. | 2017-11-07 |
| Health-e-Connect System with IDA (K163664) | Alr Technologies | 2017-09-18 |
| Glucommander (K152300) | Glytec, LLC | 2017-08-04 |
| Insulia Diabetes Management Companion (K170669) | Voluntis Sa. | 2017-06-19 |
| Insulin Algorithms System (K160673) | Insulin Algorithms | 2017-06-07 |
| My Dose Coach (K171230) | Sanofi | 2017-05-26 |
| My Dose Coach (K163099) | Sanofi, Inc. | 2017-03-22 |
| iSage Rx (iSage Rx Basal Insulin Titration) (K161865) | Isag Rx, Inc. | 2017-03-07 |
| Go Dose System (K160949) | Eli Lilly and Company | 2016-12-22 |
| Insulia Diabetes Management Companion (K161433) | Voluntis Sa. | 2016-11-09 |
| ACCU-CHEK Connect Diabetes Management App (K150910) | Roche Diabetes Care, Inc. | 2015-06-03 |
| EndoTool SubQ (K142918) | Monarch Medical Technologies | 2015-04-24 |
| ACCU-CHEK CONNECT DIABETES MANAGEMENT APP (K141929) | Roche Diagnostics Corporation | 2015-03-16 |
| REACH ACCESS TELEMEDICINE DOSE CALCULATOR (K142123) | Reach Health, Inc. | 2014-09-24 |
| GLUCOSTABILIZER INSULIN DOSING CALCULATOR (K141321) | Medical Decision Network | 2014-09-15 |
| ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) (K132547) | Monarch Medical Technologies | 2014-04-17 |
| PICIS WEIGHT BASED DOSE CONVERTER (K121542) | Picis, Inc. | 2012-08-27 |
| G+ SYSTEM (K113853) | Glytec, LLC | 2012-05-08 |
| G+ SYSTEM (K101344) | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010-06-28 |
| INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER (K082512) | Dimensional Dosing Systems, Inc. | 2008-11-07 |
| GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM (K081388) | Pronia Medical System, LLC | 2008-08-21 |
| CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR (K071713) | Medical Decisions Network | 2007-10-12 |
| ENDOTOOL DRUG DOSE CALCULATOR (K053137) | MD Scientific, LLC | 2006-06-14 |
| GLUCOMMANDER PLUS (K061110) | Collaborativemed, LLC | 2006-06-07 |
| ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE (K043529) | Roche Diagnostics Corp. | 2005-04-08 |
| TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE (K011571) | The RX Files Corp. | 2001-08-09 |
| PDT DOSECALCULATOR, MODEL 80000 (K000418) | Retinalabs.Com | 2000-10-24 |
| DC-1 I.V. DOSAGE COMPUTER (K884016) | Phase Medical, Inc. | 1988-12-20 |
| DIACARE MONITORING SYSTEM (K882001) | Healthware Corp. | 1988-10-18 |
| PHARMACOKINETICS SOFTWARE SYSTEM (PPS) (K864121) | Pharmatrol, Inc. | 1986-12-10 |
| COMPUTER ASSISTED DIABETIC INTRUCTION (K854249) | Applied Biomedical Computations, Inc. | 1986-03-27 |
| ABBOTT PHARAMACOKINETICS SYSTEMS (K851573) | Abbott Laboratories | 1986-01-08 |