FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MiniMed Go App
K Number: K253512
·
Decision Jan 8, 2026
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
54
Applicant Total
48
Review Days
63
Basic Information
- Device Name
- MiniMed Go App
- K Number
- K253512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Minimed
- Date Received
- November 6, 2025
- Decision Date
- January 8, 2026
- Product Code
- NDC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDC | Calculator, Drug Dose | FDA class 2 | Anesthesiology |
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Other Clearances by Medtronic Minimed
| K Number | Device Name | ||
|---|---|---|---|
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Feb 3, 2026 | Substantially Equivalent |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Nov 12, 2024 | Substantially Equivalent |
| K241622 | Extended Reservoir; MiniMed Reservoir | Jul 2, 2024 | Substantially Equivalent |
| K160860 | MiniMed Quick-serter | Sep 22, 2016 | Substantially Equivalent |
| K120206 | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS | Mar 29, 2012 | Substantially Equivalent |
| K100432 | POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS | Jul 9, 2010 | Substantially Equivalent |
| K073356 | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 | Apr 25, 2008 | Substantially Equivalent |
| K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E | Jan 31, 2006 | Substantially Equivalent |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | Nov 29, 2005 | Substantially Equivalent |
| K052432 | MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 | Nov 29, 2005 | Substantially Equivalent |