FDA Product Code
FDA Product Code NDC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1890
510(k) Clearances — 55 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254102 | Glucommander | Glytec, LLC | 2026-05-27 | Traditional | PDF ↗ |
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | 2026-05-01 | Traditional | PDF ↗ |
| K253512 | MiniMed Go App | Medtronic Minimed | 2026-01-08 | Traditional | PDF ↗ |
| K253281 | UpDoc | Updoc, Inc. | 2025-12-23 | Traditional | PDF ↗ |
| K252104 | T1D1 | Comerge AG | 2025-08-20 | Traditional | PDF ↗ |
| K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | 2024-12-11 | Traditional | PDF ↗ |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024-11-12 | Traditional | PDF ↗ |
| K242066 | iSage Rx | Amalgam Rx, Inc. | 2024-08-21 | Traditional | PDF ↗ |
| K232451 | Insulia Bolus Companion | Voluntis Sa. | 2023-12-12 | Traditional | PDF ↗ |
| K230813 | BlueStar and BlueStar Rx | Welldoc, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K221924 | Digital Routines | Gnc Holdings, LLC | 2023-03-15 | Traditional | PDF ↗ |
| K211160 | EndoTool SubQ 2.1 | Monarch Medical Technologies, LLC | 2021-10-28 | Traditional | PDF ↗ |
| K203434 | BlueStar Rx | Welldoc, Inc. | 2021-09-08 | Traditional | PDF ↗ |
| K202596 | Insulia Diabetes Management Companion | Voluntis Sa. | 2021-06-04 | Special | PDF ↗ |
| K201619 | EndoTool IV System | Monarch Medical Technologies, LLC | 2020-08-07 | Traditional | PDF ↗ |
| K201337 | InPen System | Companion Medical, Inc. | 2020-06-18 | Special | PDF ↗ |
| K200443 | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | 2020-03-17 | Traditional | PDF ↗ |
| K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020-02-18 | Traditional | PDF ↗ |
| K192841 | InPen System | Companion Medical, Inc. | 2020-02-10 | Traditional | PDF ↗ |
| K181916 | d-Nav System | Hygieia, Inc. | 2019-02-04 | Traditional | PDF ↗ |
| K180366 | EndoTool SubQ | Al Pacheco and Associates | 2018-09-20 | Traditional | PDF ↗ |
| K181327 | InPen Dose Calculator | Companion Medical, Inc. | 2018-07-06 | Special | PDF ↗ |
| K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018-02-02 | Traditional | PDF ↗ |
| K172177 | Insulia Diabetes Management Companion | Voluntis Sa. | 2017-11-07 | Traditional | PDF ↗ |
| K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017-09-18 | Traditional | PDF ↗ |
| K152300 | Glucommander | Glytec, LLC | 2017-08-04 | Traditional | PDF ↗ |
| K170669 | Insulia Diabetes Management Companion | Voluntis Sa. | 2017-06-19 | Traditional | PDF ↗ |
| K160673 | Insulin Algorithms System | Insulin Algorithms | 2017-06-07 | Traditional | PDF ↗ |
| K171230 | My Dose Coach | Sanofi | 2017-05-26 | Special | PDF ↗ |
| K163099 | My Dose Coach | Sanofi, Inc. | 2017-03-22 | Traditional | PDF ↗ |
| K161865 | iSage Rx (iSage Rx Basal Insulin Titration) | Isag Rx, Inc. | 2017-03-07 | Traditional | PDF ↗ |
| K160949 | Go Dose System | Eli Lilly and Company | 2016-12-22 | Traditional | PDF ↗ |
| K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016-11-09 | Traditional | PDF ↗ |
| K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015-06-03 | Special | PDF ↗ |
| K142918 | EndoTool SubQ | Monarch Medical Technologies | 2015-04-24 | Traditional | PDF ↗ |
| K141929 | ACCU-CHEK CONNECT DIABETES MANAGEMENT APP | Roche Diagnostics Corporation | 2015-03-16 | Traditional | PDF ↗ |
| K142123 | REACH ACCESS TELEMEDICINE DOSE CALCULATOR | Reach Health, Inc. | 2014-09-24 | Traditional | PDF ↗ |
| K141321 | GLUCOSTABILIZER INSULIN DOSING CALCULATOR | Medical Decision Network | 2014-09-15 | Traditional | PDF ↗ |
| K132547 | ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) | Monarch Medical Technologies | 2014-04-17 | Abbreviated | PDF ↗ |
| K121542 | PICIS WEIGHT BASED DOSE CONVERTER | Picis, Inc. | 2012-08-27 | Traditional | PDF ↗ |
| K113853 | G+ SYSTEM | Glytec, LLC | 2012-05-08 | Traditional | PDF ↗ |
| K101344 | G+ SYSTEM | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010-06-28 | Special | PDF ↗ |
| K082512 | INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER | Dimensional Dosing Systems, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K081388 | GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM | Pronia Medical System, LLC | 2008-08-21 | Traditional | PDF ↗ |
| K071713 | CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR | Medical Decisions Network | 2007-10-12 | Traditional | PDF ↗ |
| K053137 | ENDOTOOL DRUG DOSE CALCULATOR | MD Scientific, LLC | 2006-06-14 | Traditional | PDF ↗ |
| K061110 | GLUCOMMANDER PLUS | Collaborativemed, LLC | 2006-06-07 | Traditional | PDF ↗ |
| K043529 | ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE | Roche Diagnostics Corp. | 2005-04-08 | Traditional | PDF ↗ |
| K011571 | TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE | The RX Files Corp. | 2001-08-09 | Traditional | PDF ↗ |
| K000418 | PDT DOSECALCULATOR, MODEL 80000 | Retinalabs.Com | 2000-10-24 | Traditional | PDF ↗ |
| K884016 | DC-1 I.V. DOSAGE COMPUTER | Phase Medical, Inc. | 1988-12-20 | Traditional | PDF ↗ |
| K882001 | DIACARE MONITORING SYSTEM | Healthware Corp. | 1988-10-18 | Traditional | PDF ↗ |
| K864121 | PHARMACOKINETICS SOFTWARE SYSTEM (PPS) | Pharmatrol, Inc. | 1986-12-10 | Traditional | PDF ↗ |
| K854249 | COMPUTER ASSISTED DIABETIC INTRUCTION | Applied Biomedical Computations, Inc. | 1986-03-27 | Traditional | PDF ↗ |
| K851573 | ABBOTT PHARAMACOKINETICS SYSTEMS | Abbott Laboratories | 1986-01-08 | Traditional | PDF ↗ |
Product code NDC · Class II · Anesthesiology. Data: openFDA.