NDC
- Product code
- NDC
- Device name
- Calculator, Drug Dose
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1890
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 55 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254102 | 2026-05-27 | Glytec, LLC | Glucommander | |
| K260910 | 2026-05-01 | Glooko, Inc. | EndoTool IV Cloud 1.0 | |
| K253512 | 2026-01-08 | Medtronic Minimed | MiniMed Go App | |
| K253281 | 2025-12-23 | Updoc, Inc. | UpDoc | |
| K252104 | 2025-08-20 | Comerge AG | T1D1 | |
| K241088 | 2024-12-11 | Monarch Medical Technologies | EndoTool IV (3.1) | |
| K242775 | 2024-11-12 | Medtronic Minimed | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)… | |
| K242066 | 2024-08-21 | Amalgam Rx, Inc. | iSage Rx | |
| K232451 | 2023-12-12 | Voluntis Sa. | Insulia Bolus Companion |
Official FDA classification page: NDC
Classification and pathway per current FDA publications. Data from openFDA (CC0).