Product code NDC
- Device name
- Calculator, Drug Dose
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1890
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | 2026-05-01 |
| K253512 | MiniMed Go App | Medtronic Minimed | 2026-01-08 |
| K253281 | UpDoc | Updoc, Inc. | 2025-12-23 |
| K252104 | T1D1 | Comerge AG | 2025-08-20 |
| K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | 2024-12-11 |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024-11-12 |
| K242066 | iSage Rx | Amalgam Rx, Inc. | 2024-08-21 |
| K232451 | Insulia Bolus Companion | Voluntis Sa. | 2023-12-12 |
| K230813 | BlueStar and BlueStar Rx | Welldoc, Inc. | 2023-07-28 |
| K221924 | Digital Routines | Gnc Holdings, LLC | 2023-03-15 |
| K211160 | EndoTool SubQ 2.1 | Monarch Medical Technologies, LLC | 2021-10-28 |
| K203434 | BlueStar Rx | Welldoc, Inc. | 2021-09-08 |
| K202596 | Insulia Diabetes Management Companion | Voluntis Sa. | 2021-06-04 |
| K201619 | EndoTool IV System | Monarch Medical Technologies, LLC | 2020-08-07 |
| K201337 | InPen System | Companion Medical, Inc. | 2020-06-18 |
| K200443 | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | 2020-03-17 |
| K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020-02-18 |
| K192841 | InPen System | Companion Medical, Inc. | 2020-02-10 |
| K181916 | d-Nav System | Hygieia, Inc. | 2019-02-04 |
| K180366 | EndoTool SubQ | Al Pacheco and Associates | 2018-09-20 |
| K181327 | InPen Dose Calculator | Companion Medical, Inc. | 2018-07-06 |
| K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018-02-02 |
| K172177 | Insulia Diabetes Management Companion | Voluntis Sa. | 2017-11-07 |
| K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017-09-18 |
| K152300 | Glucommander | Glytec, LLC | 2017-08-04 |
| K170669 | Insulia Diabetes Management Companion | Voluntis Sa. | 2017-06-19 |
| K160673 | Insulin Algorithms System | Insulin Algorithms | 2017-06-07 |
| K171230 | My Dose Coach | Sanofi | 2017-05-26 |
| K163099 | My Dose Coach | Sanofi, Inc. | 2017-03-22 |
| K161865 | iSage Rx (iSage Rx Basal Insulin Titration) | Isag Rx, Inc. | 2017-03-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B553202153OTC0 | Conifer Connect Diabetes | WELLDOC, INC. | 2026-03-30 |
| 00199150047024 | MiniMed 780G Insulin Pump | MEDTRONIC MINIMED, INC. | 2025-11-08 |
| 00199150047000 | MiniMed 780G Insulin Pump | MEDTRONIC MINIMED, INC. | 2025-11-08 |
| 00763000827205 | inpen™ | MEDTRONIC MINIMED, INC. | 2024-06-03 |
| 00763000827182 | inpen™ | MEDTRONIC MINIMED, INC. | 2024-06-03 |
| 00763000827168 | inpen™ | MEDTRONIC MINIMED, INC. | 2024-05-31 |
| 00389152000916 | t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 2022-12-06 |
| 00389152000411 | t:slim X2 Insulin Pump with Basal-IQ | Tandem Diabetes Care, Inc. | 2022-12-06 |
| 00389152000091 | t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000077 | t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000046 | t:slim X2 Insulin Pump with Basal-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000039 | t:slim X2 Insulin Pump with Basal-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000022 | t:slim X2 Insulin Pump with Basal-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000015 | t:slim X2 Insulin Pump with Basal-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000084 | t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 00389152000107 | t:slim X2 Insulin Pump with Control-IQ | Tandem Diabetes Care, Inc. | 2022-04-15 |
| 10385083000022 | Omnipod 5 Controller | Insulet Corporation | 2022-02-25 |
| 10385081120302 | Omnipod 5 Controller APP | Insulet Corporation | 2022-02-25 |
| 00850005949046 | BioSticker™ System Offload Software | BIOINTELLISENSE, INC. | 2020-05-01 |
| 00850005949008 | BioSticker™ | BIOINTELLISENSE, INC. | 2020-05-01 |
| 10385081120036 | Omnipod | Insulet Corporation | 2018-03-05 |
| 10385081120012 | Omnipod | Insulet Corporation | 2018-03-05 |
| 10862088000368 | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. | 2017-05-01 |
| 10862088000351 | InPen Smart Insulin System | COMPANION MEDICAL, INC. | 2017-05-01 |
| 10862088000344 | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. | 2017-05-01 |
| 10862088000337 | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. | 2017-05-01 |
| 10862088000320 | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. | 2017-05-01 |
| 10862088000313 | InPen Smart Insulin Delivery System | COMPANION MEDICAL, INC. | 2017-05-01 |
| 10385081120005 | Omnipod | Insulet Corporation | 2016-09-24 |
| 10385081140003 | Omnipod | Insulet Corporation | 2016-09-23 |