K253512 is an FDA 510(k) clearance for the MiniMed Go App. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Medtronic Minimed (Los Angeles, US). The FDA issued a Cleared decision on January 8, 2026, 63 days after receiving the submission on November 6, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K253512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2025 |
| Decision Date | January 08, 2026 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDC — Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |