FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartGuard technology; Predictive Low Glucose technology
K Number: K253585
·
Decision Jan 14, 2026
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
19
Applicant Total
8
Review Days
58
Basic Information
- Device Name
- SmartGuard technology; Predictive Low Glucose technology
- K Number
- K253585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1356
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Minimed, Inc.
- Date Received
- November 17, 2025
- Decision Date
- January 14, 2026
- Product Code
- QJI
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| QJI | Interoperable Automated Glycemic Controller | FDA class 2 | Clinical Chemistry |
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Other Clearances by Medtronic Minimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253743 | MiniMed Flex pump | Mar 12, 2026 | Substantially Equivalent |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Jan 15, 2026 | Substantially Equivalent |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Aug 29, 2025 | Substantially Equivalent |
| K251032 | MiniMed 780G insulin pump | Jul 1, 2025 | Substantially Equivalent |
| K210714 | Extended Reservoir | Apr 6, 2022 | Substantially Equivalent |
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | May 19, 2015 | Substantially Equivalent |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | Oct 17, 2007 | Substantially Equivalent |