NDC — Calculator, Drug Dose Class II
FDA product code NDC covers "Calculator, Drug Dose", a Class II medical device regulated under 21 CFR 868.1890. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K254102 | glytec | Glucommander | May 27, 2026 |
| K260910 | glooko | EndoTool IV Cloud 1.0 | May 1, 2026 |
| 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 |