NDC — Calculator, Drug Dose Class II
FDA Device Classification
Classification Details
- Product Code
- NDC
- Device Class
- Class II
- Regulation Number
- 868.1890
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K253512 | medtronic minimed | MiniMed Go App | January 8, 2026 |
| K253281 | updoc | UpDoc | December 23, 2025 |
| K252104 | comerge | T1D1 | August 20, 2025 |
| K241088 | monarch medical technologies | EndoTool IV (3.1) | December 11, 2024 |
| K242775 | medtronic minimed | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | November 12, 2024 |
| K242066 | amalgam rx | iSage Rx | August 21, 2024 |
| K232451 | voluntis | Insulia Bolus Companion | December 12, 2023 |
| K230813 | welldoc | BlueStar and BlueStar Rx | July 28, 2023 |
| K221924 | gnc holdings | Digital Routines | March 15, 2023 |
| K211160 | monarch medical technologies | EndoTool SubQ 2.1 | October 28, 2021 |
| K203434 | welldoc | BlueStar Rx | September 8, 2021 |
| K202596 | voluntis | Insulia Diabetes Management Companion | June 4, 2021 |
| K201619 | monarch medical technologies | EndoTool IV System | August 7, 2020 |
| K201337 | companion medical | InPen System | June 18, 2020 |
| K200443 | monarch medical technologies | EndoTool IV 1.10 | March 17, 2020 |
| K190487 | companion medical | InPen Dose Calculator | February 18, 2020 |
| K192841 | companion medical | InPen System | February 10, 2020 |
| K181916 | hygieia | d-Nav System | February 4, 2019 |
| K180366 | al pacheco and associates | EndoTool SubQ | September 20, 2018 |
| K181327 | companion medical | InPen Dose Calculator | July 6, 2018 |